As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.


Mariscos Bahia, Inc.
Pico Rivera, CA

A food firm in California is on notice from the FDA for violations of various FDA regulations, including Salmonella in their seafood processing facility. Inspection of Mariscos Bahia Inc. was prompted by a Salmonella outbreak that was linked to fresh salmon processed at their facility.

In a Feb. 7, 2023, warning letter, the FDA described an Oct. 6-21, 2022, FDA and California Department of Public Health (CDPH) inspection of Mariscos Bahia Inc’s seafood processing facility in Pico Rivera, CA.

The FDA’s inspection revealed that the firm was not in compliance with regulations and resulted in the issuance of an FDA Form 483. 

The significant violations are as follows:

Multistate Outbreak of Salmonella Lichfield linked to Fresh Raw Salmon

The FDA, along with CDC and state and local partners, investigated this multistate outbreak of S. Litchfield infections linked to fresh, raw salmon processed by Mariscos Bahia, Inc. This investigation included 39 ill people in 4 states who were infected with the outbreak strain of Salmonella. The last illness onset was Oct. 23, 2022. WGS analysis was performed on Salmonella bacteria from the 39 ill people and showed that the Salmonella were closely related genetically to one another, indicating that ill people became sick from consuming the same food. Fifteen hospitalizations and no deaths were reported.

State and local public health officials interviewed people about the foods they ate in the week before they became ill. Of the 18 people interviewed, 13 reported eating raw fish, sushi, or poke. Of 12 people who remembered details of their meal, 10 reported raw salmon. Several ill people in the outbreak were identified as a part of three illness clusters at restaurants. 

FDA’s investigation traced the source of fresh, raw salmon eaten by people in these three illness clusters back to Mariscos Bahia, Inc.

On Oct. 6, 2022, FDA collected samples of the firm’s production environment. FDA analysis confirmed that 18 swabs were positive for Salmonella Litchfield, Salmonella Mbandaka, and/or Salmonella Oranienburg.

Whole genome sequencing analysis was conducted for the Salmonella isolates and determined that the Salmonella Litchfield environmental isolates matched the 39 clinical isolates that were from the 2022 Salmonella Litchfield outbreak referenced above. Salmonella Mbandaka was isolated in 17 swabs throughout their seafood processing environment. These isolates match each other and have an inconclusive relationship to a feed isolate from Germany and 20 clinical isolates from the U.S., Germany, and U.K. Additionally, Salmonella Oranienburg was isolated from 1 swab (was found to have both Salmonella Mbandaka and Salmonella Oranienburg) in their processing facility. It has an inconclusive relationship with one clinical isolate. The FDA advised them of the importance of these WGS results via conference calls on Oct. 17 and 19, 2022. During both calls, FDA provided detailed examples of corrective actions their firm could implement in response to the findings.

Based on the epidemiologic, traceback, and laboratory data, fresh salmon processed by Mariscos Bahia Inc are the likely source of this outbreak of the Salmonella Litchfield infections.

Salmonella species are not endemic to seafood; therefore, FDA expects zero or non-detectable levels of Salmonella in seafood regardless of whether it is intended to be cooked before consumption or it is ready-to-eat (RTE). Salmonella in seafood is the result of human or animal fecal contamination of the harvest waters and/or fecal contamination during post-harvest handling and processing. The contamination can also be exacerbated by temperature abuse. Raw RTE seafood must have appropriate controls from harvest to consumption. 

The presence of Salmonella in the firm’s facility is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their facility to prevent contamination of food. When product is exposed to the environment, inadequate sanitation and poor employee practices may lead to product contamination with pathogens in the environment, like Salmonella.

If the contaminated fish is consumed raw or without being cooked adequately to sufficiently kill the pathogen, then people who consume the contaminated product may become ill. Although the firm may intend that their fresh salmon be cooked by the end-user, the outbreak investigation found that many of their customers served their fresh salmon raw. They are required to control the pathogenic hazard of Salmonella in their facility so that the food they produce is not adulterated and does not cause foodborne illness. The firm’s control strategy of placing a statement on their invoices that instructs their customers to freeze their fresh fish products will not control pathogenic bacteria such as Salmonella. Rather, freezing at appropriate temperatures can be used as a control for parasites.

The full warning letter can be viewed here.

Wise Spice Catering Company
Hialeah, FL

A food firm in Florida is on notice from the FDA for violations of federal regulations in their facility, including the presence of Listeria monocytogenes and insects throughout the facility.

In a March 8 warning letter, the FDA described an April 19 through Aug. 1, 2022, inspection of Wise Spice Catering Company’s ready-to-eat (RTE) food facility in Hialeah, FL.

The FDA’s inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. These violations resulted in the issuance of an FDA Form 483. The significant violations are as follows:

Pathogen Findings
FDA’s inspection included the collection of environmental swabs which found that 19 swabs were confirmed positive for L. monocytogenes. Of the positive findings, one swab was collected from the food-contact surface of a prep table in the (redacted) Room used in the assembling of the firm’s RTE closed faced sandwiches, and one swab was collected from the food-contact surface of a black milk crate holding raw tomatoes and onion used in RTE closed faced sandwiches and salads. This was not the first time Listeria monocytogenes was found in environmental samples collected in their facilities building. In 2020, FDA detected Listeria monocytogenes in six environmental swabs; in 2018, FDA detected Listeria monocytogenes in nine environmental swabs; and in 2017 FDA detected Listeria monocytogenes in 18 environmental swabs.

On May 6, 2022, the United States Department of Agriculture (USDA) Food Safety Inspection Service (FSIS) notified FDA of one environmental sample collected from non-food contact surfaces at their facility which tested positive for Listeria monocytogenes. This was not the first time Listeria monocytogenes was found by USDA/FSIS in environmental samples collected in their facilities building. In 2015, USDA/FSIS also detected Listeria monocytogenes in one environmental sample.

Moreover, on May 31, 2022, the Florida Department of Agriculture and Consumer Services (FDACS) collected finished product samples of a Ham, Egg and Cheese Sandwich and a Beef, Beans Rice Cheese Burrito (contained (redacted) percent beef) which both tested positive for Listeria monocytogenes. On June 10, 2022, FDACS issued the firm a Stop Sales Order and Destruction for their sandwich products and issued a Stop Use Order on their (redacted) Preparation Room, preventing the use of this room in their manufacturing operation. This is not the first time FDACS has isolated Listeria monocytogenes from their finished products; in 2015 finished product samples of a Tuna Sandwich, Ham Sandwich, Midnight Regular Sandwich, Ham Wrap Sandwich, Deli Ham Sandwich, and Ham Omelet Sandwich tested positive for Listeria monocytogenes.

Whole genome sequencing (WGS) was conducted on the above referenced Listeria monocytogenes isolates obtained from the FDA environmental samples, USDA/FSIS environmental samples, and FDACS product samples. Based on the results of the WGS analysis, these isolates represent 18 different strains of Listeria monocytogenes. The WGS analysis identified multiple strains of Listeria monocytogenes isolated over multiple years which is indicative of the presence of resident pathogens or harborage sites in their facility. FDA advised the firm of the WGS results and its importance on June 21, 2022. Of the 18 identified strains, the following nine strains of are particular significance:

  • One strain includes isolates from FDA environmental samples collected from their facility in 2022, 2020, 2018, and 2017, the May 31, 2022 FDACS product sample of Ham Egg Cheese Sandwich which was manufactured at their facility, an environment sample collected from non-food contact surfaces at their facility in 2022 by USDA/FSIS, and environmental samples collected from other firm(s) located in Florida.
  • One strain includes an isolate from their Beef Beans Rice Cheese Burrito product sample collected by FDACS on May 31, 2022, which does not match any other food, environmental, or clinical isolates in the National Center for Biotechnology Information (NCBI) Pathogen Detection database.
  • One strain includes isolates from FDA environmental samples collected from their facility in 2017 and a 2015 FDACS product sample of Tuna Sandwich which was manufactured at their facility.
  • One strain includes isolates from an FDA environmental sample collected from their facility in 2017, a 2015 FDACS product sample of Ham Sandwich which was manufactured at their facility, an environment sample collected from non-food contact surfaces at their facility in 2015 by USDA/FSIS, an environmental sample collected from another of their sandwich manufacturing facilities (Charanga Catering, LLC located in Florida), and an environmental sample collected from one firm located in Florida.
  • One strain includes isolates from FDA environmental samples collected from their facility in 2022, a 2015 FDACS product sample of Ham Omelet Sandwich which was manufactured at their facility, and environmental and product isolates collected from other firm(s) located in Florida.
  • One strain includes isolates from FDA environmental samples collected from their facility in 2018 and 2017, a 2015 FDACS product sample of a Midnight Regular Sandwich which was manufactured at their facility, and environmental and product samples collected from other firm(s) located in Florida.
  • One strain includes isolates from FDA environmental samples collected from their facility in 2017, 2015 FDACS product samples of a Deli Ham Sandwich and Ham Wrap Sandwich, which were manufactured at their facility, and environmental and product isolates collected from other firm(s) located in Florida.
  • One strain includes isolates from FDA environmental samples collected from their facility in 2022 and 2020, four samples collected from ill people which were deposited in the public repository at the NCBI between 2014 and 2021, and UDSA/FSIS food and environmental isolates collected from firms located in Florida, Texas and New York. These findings demonstrate that this strain is known to cause human illness.
  • One strain includes isolates from an FDA environmental sample collected from their facility in 2022, a sample collected from an ill person which was deposited in the public repository at the NBCI in 2016 and food samples collected by USDA Agricultural Research Service. These findings demonstrate that this strain is known to cause human illness.

The presence of Listeria monocytogenes in their facility and their products is significant in that it demonstrates their sanitation efforts are inadequate to effectively control pathogens in their facility to prevent contamination of food. Appropriate control of Listeria monocytogenes in a food processing environment requires knowledge of the unique characteristics of the organism and implementing the corresponding hygienic practices necessary to control this pathogen. FDA findings indicate that their firm is neither achieving satisfactory control against the presence of Listeria monocytogenes within their facility nor implementing effective methods and controls to eliminate this human pathogen or minimize exposure to food and food-contact surfaces. Once it is established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as are necessary to eradicate the organism.

Given the history and current inspection findings, FDA continues to be concerned about their ability to maintain a sanitary environment. FDA recommend that they identify potential harborage sites and source(s) of the organism in their processing environment and implement the necessary methods and controls to ensure Listeria monocytogenes does not contaminate their environment or their RTE food products.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):

1. The firm did not take effective measures to exclude pests from their packing and holding areas and to protect against the contamination of food on the premises by pests. Specifically, insect activity was observed throughout their facility including the following:

a. One live cockroach was observed on an empty brown plastic crate used to store and transport RTE packaged foods for customer orders, with crate directly next to stainless steel packaging tables in the front packaging/sales area.
b. Approximately eight live apparent cockroaches were observed moving between metal panel and wall, and on the floor next to large kettles used for meat and black beans next to the side exit door in the shared USDA-regulated kitchen area.
c. One apparent live German cockroach was observed crawling on the floor outside the FDA-regulated kitchen moving towards the wash room.
d. Apparent flies, too numerous to count, were observed throughout various processing areas of the facility including: the front packaging and sales area with flies landing on scales, equipment and packages of cooked ready-to-eat foods such as rice, beans, eggs, and fries; inside the kitchen during food preparation and packaging; and dry storage area.
e. Two apparent flies were observed landing on an uncovered metal tray of cooked yuca in the front sales and packaging area, prior to an employee moving the tray inside the walk-in cooler to be cooled.
f. A plastic tray with packages of rice, beans, and plantains was observed with apparent bird excreta in the front sales area.

2. The firm’s plant is not constructed in such a manner that drip or condensate from fixtures, ducts and pipes does not contaminate food, food contact surfaces, or food packaging materials, as required. Specifically,

a. Condensation was observed on the underside of condensing unit located directly above stainless-steel processing table used to manufacture closed-face sandwiches; and was observed dripping onto surface of processing table, inside the (redacted) processing room.
b. Condensation was observed on the black pipe cover under condensing unit, directly above a storage rack used to store raw materials, dripping onto a cardboard box with margarine and onto the floor inside (redacted) #1.

3. The firm did not maintain their plant in a clean and sanitary condition, and they did not clean and sanitize their utensils or equipment in a manner that protects against contamination, as required. Specifically,

a. During FDA inspection investigators observed stagnant water on a number of occasions, including on the floor and around floor drains in the front sales and food preparation area, on the floor with cracks and patches under storage racks holding cooked rice; on missing patches of floor near condensing unit inside (redacted) #1 used to store RTE food products such as closed-faced sandwiches; and on missing patches of floor at entrance to the (redacted) room.
b. An employee preparing to make RTE closed face sandwiches used an unclean knife to cut open packages of cooked deli ham blocks. The employee brought the knife from the USDA-regulated processing side and did not clean or sanitize the knife prior to cutting. Additionally, the investigator observed the knife had orange dried food residue near the white handle.

4. The firm did not hold food that can support the rapid growth of undesirable microorganisms at temperatures that will prevent the food from being adulterated, as required. Specifically, the firm did not hold their RTE food products at adequate temperatures. FDA investigators observed RTE food products being held in their customer sales area under ambient conditions for an extended period of time.
Specifically,

a. FDA investigators observed that on April 21, 2022, from (redacted) to (redacted), their scrambled eggs with onion and peppers product was available for sale. FDA investigators measured their product temperature using an FDA calibrated thermometer, reporting that their scrambled eggs with onion and peppers product temperature was (redacted)°F (redacted) hours after its preparation.
b. FDA investigators observed that on April 21, 2022, from (redacted) to (redacted) their boiled cassava “yuca” product was available for sale. FDA investigators measured their product temperature using an FDA calibrated thermometer, reporting that their boiled cassava “yuca” product temperature was (redacted)°F (redacted) hours after its preparation.

The full warning letter can be viewed here.

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This year saw the Centers for Disease Control and Prevention issue notices on 11 multi-state foodborne illness outbreaks, ranging from ground beef to strawberries.

The Food and Drug Administration’s Coordinated Outbreak Response and Evaluation Network (CORE) investigated 28 outbreaks, with three of those investigations remaining open as of Dec. 28. For 14 of the FDA investigations a specific food source was not determined.

The discrepancy between the numbers from CDC and FDA is likely because the CDC generally only posts outbreak notices after a specific food source has been identified. Also, the CDC only serves as the lead investigative entity on multi-state outbreaks. For single-state outbreaks, state and local agencies are the investigators, with the CDC sometimes providing secondary assistance, which does not result in the federal agency posting an outbreak notice.

Also possibly responsible for the different number of outbreaks being reported by the FDA and CDC is that the FDA does not publicly report where outbreak patients live, so it is not possible for the public to tell whether an outbreak involves more than one state. Presumably, the FDA shares such information with the CDC’s outbreak investigators.

At least two multi-state outbreaks occurred that the CDC did not include in its official listing for 2022. One involved more than 500 people who reported “adverse events” related to eating Lucky Charms breakfast cereal. The FDA investigated the outbreak, but no recall was issued. The investigation was closed.

The other multi-state outbreak not listed by the CDC involved four babies who were fed infant formula produced by an Abbott Nutrition plant in Michigan. Two of the babies died. The pathogen involved was cronobacter, but the company continues to deny that any of its products are related to illnesses or deaths. However, the production plant was closed down for months for deep cleaning and was only allowed to reopen under the strict regulation of the FDA.

In all outbreaks, the CDC cautions that the number of patients is likely much higher than those reported because symptoms can mimic other illnesses and many people are not tested for specific foodborne pathogens. Also, some people may recover without seeking medical attention.

The CDC issued notices on the following 11 outbreaks in 2022.

A norovirus outbreak linked to raw oysters from a specific harvest area in Texas had sickened 298 people as of Dec. 20. The states with patients are Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, Tennessee, and Texas. The investigation remained active as of Dec. 28. Officials in several states initiated recalls of oysters harvested in a specific area in the Galveston, TX, area. The CDC is continuing trace-forward efforts to try to determine where the oysters were shipped. Freezing does not kill norovirus, and they could still be served as “raw” after being thawed. The CDC has not reported if any patients have been hospitalized or died.

A two-state outbreak of infections from Listeria monocytogenes remains under investigation after having first been reported by the CDC on Nov. 17. At that time the CDC reported that two people in two states had become infected. Both have required hospitalization. Investigators are working to identify specific brands of enoki mushrooms linked to these illnesses. A wide variety of imported enoki mushrooms sold under various brands were recalled in 2022 because of Listeria contamination.

A six-state outbreak of infections from Listeria monocytogenes has been traced to deli meats and cheeses and remains under investigation. Sixteen people have been infected, with 13 of them requiring hospitalization. One patient has died and one pregnant patient lost her baby. The CDC reported the outbreak on Nov. 9 this year. Sick people’s samples were collected from April 17, 2021, to Sept. 29, 2022. The CDC did not identify a single source of the Listeria but did find that five of the patients bought deli meats and cheeses from NetCost Market, an East Coast grocery chain. Other delis and grocery stores were not ruled out as sources. “A contaminated food likely introduced the outbreak strain of Listeria into delis in multiple states,” the CDC reported. The CDC and FDA routinely remind deli owners that their equipment can easily harbor Listeria and should be cleaned regularly. The CDC suggested that people at high risk of infection, such as pregnant women, the elderly, and people with compromised immune systems should avoid deli meats and cheeses.

A four-state outbreak of Salmonella Litchfield was declared over on Dec. 14. The outbreak sickened 39 people and resulted in 15 hospitalizations. No deaths were reported. Investigators found that fresh fish sold by Mariscos Bahia Inc. was responsible for the illnesses. The CDC first reported the outbreak on Oct. 20. Illnesses started on dates ranging from June 14 to Oct. 23 this year. An FDA investigation traced the source of fresh, raw salmon eaten by sick people back to Mariscos Bahia, Inc. On Oct. 20, Mariscos Bahia Inc. recalled fresh salmon, Chilean seabass, halibut, tuna, and swordfish.

A six-state outbreak of infections from E. coli O121 that was first reported by the FDA on Oct. 12 was reported by the CDC on Oct. 7. The outbreak was declared over as of Dec. 1. There were 24 people confirmed infected with five having required hospitalization. Illnesses started on dates ranging from July 13, 2022, to Oct. 24, 2022. Frozen Earth Grown brand Vegan Traditional Falafel and Garlic & Herb Falafel sold at Aldi stores was found to be the source of the pathogen. On Oct. 7, 2022, Cuisine Innovations of Lakewood, NJ, recalled the implicated products.

A six-state outbreak of infections from Listeria monocytogenes, which was declared over on Dec. 9, sickened six people with five of them requiring hospitalization. Investigators found that cheese made by Old Europe Cheese, Inc. made people in this outbreak sick. On Sept. 30, Oct 4, and 5 the company called several varieties and brands of brie and camembert cheeses. Some of the cheese had expiration dates of Dec. 14, but the CDC declared the outbreak over despite the fact that it can take up to 70 days for symptoms of Listeria infection to develop. 

A six-state outbreak of infections from E. coli O157:H7 sickened seven people, with six of them requiring hospitalization. Investigators found that ground beef in Hello Fresh meal kits was responsible for the outbreak. The outbreak was declared over on Oct. 28. Illnesses started on dates ranging from June 8 to Aug. 17. There was concern that consumers may have had the frozen ground beef in their freezers well after the last reported illness onset, so the investigation was kept open for quite some time after the last illness was reported.

A six-state outbreak of infections from E. Coli O157:H7 sickened 109 people, with 52 of them requiring hospitalization. No one died. The illnesses were associated with people who ate sandwiches from Wendy’s restaurants that had romaine lettuce on them. The CDC stopped short of making a specific connection between the romaine and the illnesses. “. . .this outbreak ended before enough information could be gathered to determine the source of the outbreak,” the CDC reported. Illnesses started on dates ranging from July 26 to Aug. 17. The outbreak was declared over on Oct. 4.

An 11-state outbreak of infections from Listeria monocytogenes sickened 28 people, hospitalizing 27 and killing one. Seven illnesses were among pregnant people or newborns. One illness resulted in a pregnancy loss. Illnesses started on dates ranging from Jan. 24, 2021, to June 24, 2022. The source was traced to ice cream made by Big Olaf’s Creamery in Florida. State testing showed 16 of 17 flavors of the ice cream were contaminated with the pathogen. Florida state officials shut down the business. The recalled ice cream was sold or served at Big Olaf retailers, restaurants, and senior homes in Florida, and in one location in Fredericksburg, OH. The outbreak was declared over on Nov. 7. 

A four-state outbreak of hepatitis A infections was traced to strawberries. The outbreak sickened 19 people and resulted in 13 hospitalizations. Fresh organic strawberries branded as FreshKampo or HEB were determined to be the source of the pathogen. The fresh organic strawberries were imported from Baja California, a state in northern Mexico. Illnesses started on dates ranging from March 28, 2022, to May 6, 2022. The CDC closed its investigation on Aug. 14. The strawberries were likely sold at retailers, including, but not limited to HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe’s, Walmart, Weis Markets, and WinCo Foods.

A 17-state outbreak from Salmonella Senftenberg sickened 21 people, resulting in four hospitalizations. The source was determined to be Jif brand peanut butter, which was recalled by the J.M. Smucker Co. The recall resulted in numerous downstream recalls of products that had peanut butter as an ingredient. Illnesses started on dates ranging from Feb. 20, 2022, through May 24, 2022. The outbreak was declared over on July 27. 

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The federal government has closed some foodborne illness outbreak investigations in the past week.

The USDA’s Food Safety and Inspection Service released even less information when it closed its investigation into an outbreak than it did when it announced it. Of infections caused by E. coli O157:H7 the agency merely reported that beef was the suspected vehicle for the pathogen. The investigation, which began on an unspecified date in November is now closed. The agency did not report how many people were sickened or where they lived.

Similarly, few details were provided by the Food and Drug Administration for an outbreak of infections from Salmonella Typhimurium for which the investigation remains open. At least 274 people have been sickened in the outbreak from an unknown source. The FDA did not report where they live. Traceback and sample analysis was initiated, but the agency did not report what food or foods are involved.

Both the FDA and Centers for Disease Control and Prevention report that an outbreak traced to frozen falafel sold under the Earth Grown brand and sold at Aldi stores has ended with 24 illnesses across six states. Five people required hospitalization.

The CDC and FDA are reporting that a Salmonella outbreak traced to fish has ended with 39 people sick across four states. Fifteen people required hospitalization. Several sick people reported eating from three restaurants before getting sick, and Mariscos Bahia, Inc. was the supplier. On Oct. 20, 2022, Mariscos Bahia, Inc. recalled fresh (not frozen) salmon, Chilean seabass, halibut, tuna, and swordfish.

The FDA and CDC have also declared that an outbreak of Listeria monocytogenes infections linked to soft cheeses has ended. Cheese made by Old Europe Cheese Inc. was implicated in the outbreak that sickened six people across six states. Five people had to be hospitalized. Many brands of brie, camembert, and baked brie cheeses were recalled in September and October. These cheeses had best-by dates through Dec.14, 2022.

As for open investigations, the FDA and CDC continue to search for details in a Listeria monocytogenes outbreak traced to enoki mushrooms. Concerns about many brands of enoki mushrooms continue. In 2020, CDC investigated the first known Listeria outbreak in the United States linked to enoki mushrooms. This outbreak resulted in three recalls of enoki mushrooms that were imported from Korea. Since then, the U.S. Food and Drug Administration (FDA) and public health officials from several states have been collecting samples of enoki mushrooms and found Listeria in many samples, resulting in more than 20 recalls of enoki mushrooms.

The FDA and CDC continue to investigate an outbreak of infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI. The company says its internal tests have not found the pathogen and denies any ties to the illnesses or deaths.

Additional outbreak information
Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

(To sign up for a free subscription to Food Safety News, click here)

The FDA and USDA continue to investigate outbreaks with the sources of the pathogens remaining unknown.

The USDA’s Food Safety and Inspection Service have posted virtually no information on the outbreak it has been investigating except to say that the pathogen is E. coli in beef. The agency has not said how many people have been sickened or where they live. It appears that FSIS closed another investigation linked to Salmonella and beef that also sickened an unknown number of people.

On the Food and Drug Administration’s side of the outbreak coin, the agency has begun sample collection and analysis in an outbreak linked to enoki mushrooms. The Listeria monocytogenes outbreak has sickened at least people in two states. Both have been hospitalized. The Centers for Disease Control and Prevention reports that the investigation is trying to determine what brand or brands are involved.

Another outbreak, the FDA is continuing to investigate although the outbreak has ended. There have been 270 people sickened from Salmonella Typhimurium, but the FDA has not reported their ages or states of residence. The outbreak has been determined to be over, but FDA investigators continue to look for its cause.

Other FDA ongoing investigations 

  • For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. Recall information was updated on Oct. 28. It reported that seven patients from six different states have been confirmed ill. Five have been hospitalized, according to the CDC.
  • For an outbreak of infections from Salmonella traced to seafood, the FDA continues to work on the investigation with the CDC. A total of 33 patients in California, Illinois, and Arizona have been confirmed, with 13 of them requiring hospitalization. Several varieties of seafood totaling more than 150 tons and supplied by Mariscos Bahia, Inc. have been recalled
  • An outbreak investigation continues for infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI. The company says its internal tests have not found the pathogen and denies any ties to the illnesses or deaths.
Click on table to enlarge. Use link below to go to FDA page with links to specific outbreak information.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

(To sign up for a free subscription to Food Safety News,click here)

An outbreak of infections from Salmonella Typhimurium is slowly growing according to the FDA, and an investigation into an outbreak of E. coli infections has been closed.

For the Salmonella outbreak, the number of patients has increased from 264 to 269, but the Food and Drug Administration has not reported the patients’ states of residence. 

The agency has begun traceback efforts but has not revealed what food or foods are being traced. The FDA has begun sample collection and analysis, but has not revealed what is being collected or sampled.

For the E. coli outbreak investigation that has been closed, the agency found 11 patients but did not identify a source for the pathogen. The FDA conducted traceback but did not reveal what food or foods were traced. The agency did not report the patients’ states of residence.

For an outbreak of infections from Listeria monocytogenes in enoki mushrooms the FDA reported that the CDC has confirmed two patients, one in Michigan and one in Nevada. Both have required hospitalization. The most recent illness onset was Nov. 15.

“Investigators are working to identify specific brands of enoki mushrooms that may be linked to these illnesses,” according to an outbreak announcement from the Centers for Disease Control and Prevention.

“The true number of sick people in this outbreak is likely higher than the number reported, and the outbreak may not be limited to the states with known illnesses. This is because some people recover without medical care and are not tested for Listeria.”

Also, it can take up to 70 days for symptoms to develop, and the CDC says it can take three to four weeks to determine whether a person is part of an outbreak.

Other ongoing FDA outbreak investigations

  • For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. Recall information was updated on Oct. 28. It reported that seven patients from six different states have been confirmed ill. Five have been hospitalized, according to the CDC.
  • For an outbreak of infections from Salmonella traced to seafood the FDA continues to work on the investigation with the CDC. A total of 33 patients in California, Illinois and Arizona have been confirmed, with 13 of them requiring hospitalization. Several varieties of seafood totaling more than 150 tons and supplied by Mariscos Bahia, Inc. have been recalled
  • The FDA has begun traceback and sample collection in an outbreak of E. coli O121:H19 linked to frozen falafel sold at Aldi stores in 36 states. At least 20 people had been confirmed sick as of Oct. 7, the date of the most recent update. Sick people have been confirmed in Florida, Iowa, Kansas, Michigan, Ohio, and Wisconsin. The most recent illness onset was Sept. 13.
  • An outbreak investigation continues for infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI. The company says its internal tests have not found the pathogen and denies any ties to the illnesses or deaths.
Click on table to enlarge. Use link below to go to FDA page with links to specific outbreak information.

Click here to go to the FDA page with links to specific outbreak details. The investigations are in a variety of stages. Some outbreaks have limited information with active investigations ongoing, others may be near completion.

public health advisory will be issued for investigations that have resulted in specific, actionable steps for consumers to take to protect themselves, according to the FDA. Please direct your attention to those pages for the most up-to-date information on the investigation and for consumer protection information.

Outbreak and adverse event investigations that do not result in specific, actionable steps for consumers may or may not conclusively identify a source or reveal any contributing factors. Adverse event investigations rely on self-reported data. Although these reports may name a particular product, FDA will only indicate a product category in the table and will not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events. If a cause and/or contributing factors are identified that could inform future prevention, FDA commits to providing a summary of those findings.

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Mariscos Bahia Inc. is recalling over 300,000 pounds of salmon, halibut, seabass, tuna and swordfish because of possible Salmonella contamination.

Products were distributed to 179 retail customers located in Arizona and California, primarily to restaurants.

According to the Food and Drug Administration, the recall was initiated on Oct. 20, and is ongoing.

Recalled products:

#Product DescriptionRecall NumberClassificationCode InformationProduct Quantity
1Fresh Salmon fillets packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0083-2023Class IProduct code: SALFFS89,953 lbs
2Halibut (fillets and portions) packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0084-2023Class IProduct code: HALL, HALP, HALP85,718.23 lbs.
3Chilean Seabass (fillets and portions) packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0085-2023Class IProduct code: SEA003, SEA0043,307.89 lbs
4Tuna (fillet and loins) packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0086-2023Class IProduct code: TUN0033,998.28 lbs
5Swordfish (loins, fillets, and Wheels) packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0087-2023Class IProduct Code: SWF, SWF012,685.77 lbs
6Fresh Salmon Fillet Portions (6,7,8,9,10 oz.) packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0088-2023Class IProduct Code: SALPFS179,002.40 lbs.
7Fresh Salmon Deep Skin Fillets packed in 10-50 lb. corrugated cardboard or Styrofoam boxesF-0089-2023Class IProduct Code: SALFDS40,338.15 lbs

About Salmonella infections
Food contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled. Anyone can become sick with a Salmonella infection. Infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile, according to the CDC.

Anyone who has eaten any of the recalled fish and developed symptoms of Salmonella infection should seek medical attention. Sick people should tell their doctors about the possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis. Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis.

Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization.

Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and serious, sometimes life-threatening conditions.

Some people get infected without getting sick or showing any symptoms. However, they may still spread the infections to others.

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The FDA is continuing to investigate several foodborne illness outbreaks and has added a new one to its list.

As of Oct. 26, there had been 10 patients confirmed in the new outbreak of infections from E. coli O157:H7. The Food and Drug Administration has initiated traceback but has not reported what food or foods are being traced.

In other outbreak news, the FDA has issued an outbreak advisory for an outbreak of infections from Salmonella Litchfield in seafood. As of this past week, there were 33 confirmed patients in the outbreak. The FDA has been investigating the outbreak since late September and has traced the implicated fish to Mariscos Bahia Inc.

For two multistate outbreaks from the Cyclospora cayetanensis parasite, one with 84 patients and the other with 43, the FDA is reporting that sick people said they ate a variety of leafy greens before becoming ill. The FDA has closed both investigations. 

“For both investigations, CDC, FDA, and state and local partners conducted epidemiologic and traceback investigations and collected and analyzed the product and environmental samples. All samples collected were reported as negative for Cyclospora. Due to the lack of additional detail in the epidemiological data and the absence of supporting evidence collected from traceback and sample collection, FDA could not identify a specific product as the source of either outbreak,” according to an FDA update on the two outbreaks.

The FDA has closed investigations on two other outbreaks.

One of the outbreaks, from Salmonella Senftenberg, sickened 36 people. The FDA did not identify a source for Salmonella and the outbreak is considered over.

The other outbreak investigation has closely involved frozen crumbles sold under the Daily Harvest brand. The leek and lentil crumbles were associated with 393 consumer complaints of various illnesses including liver, bile duct, and gallbladder issues. At least 133 people were hospitalized and at least 25 patients reported they had to have their gallbladders removed. One possible source of the illnesses was tara flour used in the crumbles, but the FDA did not find a definitive link. The most recent person to become sick had symptoms begin on Sept. 4. 

Ongoing outbreak investigations

  • For a Listeria monocytogenes outbreak from Brie and Camembert cheese an Outbreak Advisory was issued on Sept. 30. It reported that six patients from six different states have been confirmed ill. Five have been hospitalized, according to the CDC.
  • The FDA has begun traceback and sample collection in an outbreak of E. coli O121:H19 linked to frozen falafel sold at Aldi stores in 36 states. At least 20 people had been confirmed sick as of Oct. 7. Sick people have been confirmed in Florida, Iowa, Kansas, Michigan, Ohio, and Wisconsin. The most recent illness onset was Sept. 13.
  • The FDA is conducting an on-site inspection at Big Olaf Creamery in Florida, which has been deemed to be behind an 11-state outbreak of Listeria infections. The state of Florida closed the business several weeks ago after tests found multiple places of contamination with Listeria monocytogenes in the plant. Testing also showed Listeria in 16 of 17 flavors of the company’s ice cream. At last count, the outbreak had sickened 25 patients with one having died. A pregnant woman also miscarried. Twenty-four of the patients have required hospitalization.
  • An outbreak of infections from Cronobacter in at least four infants, two of whom died. The outbreak has been determined to be over by the CDC but is it still under investigation. The babies consumed infant formula made by Abbott Nutrition’s plant in Sturgis, MI.
Click on the table to enlarge it. Use the link below to go to the FDA page with links to specific outbreak information.

Click here to go to the page with links to specific outbreaks.

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More than 30 people have been confirmed sick in an outbreak of Salmonella Litchfield infections traced to fresh raw salmon.

Of the 33 patients, 16 have completed interviews with health officials and 12 of those reported eating sushi, sashimi, or poke. Thirteen of the 33 patients have been so sick that they had to be admitted to hospitals, according to the Centers for Disease Control and Prevention.

The Food and Drug Administration has been investigating the outbreak since late September and has traced the implicated fish to Mariscos Bahia Inc. The FDA found multiple environmental samples from the company’s Pico Rivera, CA, distribution center to be contaminated with Salmonella. Some of the fish could have been sent to the Mariscos Bahia Inc. facilities in Phoenix, AZ, and then sent to restaurants.

There has not been a recall. According to Mariscos Bahia Inc., seafood was only sold directly to restaurants in California and Arizona and would not be available for purchase by consumers in stores.

“While epidemiological evidence indicates that ill people consumed fresh, raw salmon processed at this firm, the presence of Salmonella in the processing environment indicates that additional types of fish processed in the same area of the facility could also be contaminated which includes fresh, raw halibut, Chilean seabass, tuna, and swordfish,” according to the FDA.

The salmon was supplied to restaurants in California and Arizona. There are 21 patients in California, 11 in Arizona and one in Illinois. The most recent illness onset was Sept. 18.

The FDA recommends that restaurants check with their suppliers and not sell or serve fresh salmon, halibut, Chilean seabass, tuna, and swordfish received fresh, not frozen from Mariscos Bahia Inc. distribution centers in Pico Rivera, CA, and Phoenix, AZ.

“If restaurants received these fish and then froze it, they should not sell or serve it. Restaurants should also be sure to wash and sanitize locations where these fish from Mariscos Bahia, Inc. were stored or prepared, adoring to the FDA.

“Consumers eating salmon, halibut, Chilean seabass, tuna, and swordfish at a restaurant in California or Arizona should ask whether the fish is from Mariscos Bahia, Inc and was received fresh, not frozen.”

About Salmonella infections
Food contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled. Anyone can become sick with a Salmonella infection. Infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile, according to the CDC.

Anyone who has developed symptoms of Salmonella infection should seek medical attention. Sick people should tell their doctors about the possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis. Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis.

Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization.

Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and serious, sometimes life-threatening conditions.

Some people get infected without getting sick or showing any symptoms. However, they may still spread the infections to others.

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