A Texas beef cattle operation, a Puerto Rican fruit juice processor, and three seafood processors in New Jersey, New York and Poland are all on notice from the Food and Drug Administration for violations of federal food safety rules.
The FDA sent the warning letters to the companies in August and September, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.
In all five warning letters, the FDA acknowledged the Texas cattle operation’s, Puerto Rican fruit juice processor’s, and the New Jersey, New York, and Poland seafood processors’ promised corrective actions. Yet, all five responses were determined “insufficient” to meet the expected corrective actions, according to the FDA warning letters.
Adrian J. Mortimer beef cattle operation Stephenville, TX
In an Aug. 15 warning letter to owner Adrian J. Mortimer, the FDA described violations observed during an inspection May 2-4, in Stephenville, TX. Mortimer sells animals for slaughter as food, that they transport and deliver, according to the warning letter.
All producers of animals offered for use as food, are responsible for ensuring that their overall operation and the food they distribute is in compliance with the law. According to the warning letter, the cattle were held under insanitary conditions whereby they may have been rendered injurious to health.
“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply,” according to the warning letter.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) analysis of tissue samples collected from the processor’s animal identified the presence of residues, including penicillin at 1.193 parts per million (ppm) in kidney tissue; at 33.164 ppm in liver tissue; and flunixin at 0.542 parts per billion (ppb)in liver tissue.
The FDA said the processor also admitted to medicating the animal with these drugs before delivering it to slaughter. The FDA has established a tolerance of 0.05 ppm for residues of penicillin in kidney tissue; and 0.125 ppb flunixin in the liver of cattle.
“The presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).”
The FDA noted the following additional violations:
- The processor failed to maintain treatment records for animals that they medicate;
- They had no inventory system for determining the quantities of drugs used to medicate their animals;
- They failed to maintain records regarding the identity of the animal(s) that they transport and deliver for slaughter; and
- They had expired drugs on their premises.
Additionally, FDA investigators said that on or about Jan. 25, 2017, the processor provided a form titled “FDA Compliance for BSE and Drug Residue” that states that the animals presented for slaughter do not have an illegal level of drug residues. On or about that date the processor delivered a beef steer calf which contained violative residues of penicillin and flunixin.
“Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h).”
Distribuidora La Jugosita Inc. Cidra, Puerto Rico
In a Sept. 1 letter to president William Rodriquez, the FDA cited serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, and the Current Good Manufacturing Practice (CGMP) regulation for food. The FDA discovered and documented problems at the Cidra, Puerto Rico, juice facility April 26 through May 16.
According to the warning letter, the FDA observed the following significant deviations:
- The firm was not monitoring the sanitation conditions and practices adequately and with sufficient frequency, specifically failing to monitor the exclusion of pests; the prevention of cross-contamination; the protection of food, food packaging material, and food contact surfaces from adulteration; and the condition and cleanliness of food contact surfaces.
- The firm failed prevent the ingress of pests such as lizards and cockroaches.
- The firm failed to store raw materials in a manner that protects against contamination and minimizes deterioration, specifically the fruit juice concentrate, pulps, blends, and baskets containing fruit beverage containers were observed stored against the wall in a walk-in cooler located at the front premises of the facility.
- The firm’s walk-in freezer was crowded, and containers held at the unit were not capable of inspection, thus, the observed storage conditions do not provide for the proper cleaning of the storage units.
The FDA added that some of the above violations were, “a repeat observation from the 2011 and 2009 inspections.”
Wilbo S.A. Pomorskie, Poland
In an Aug. 8 warning letter to president Grzegorz Biatoruski, the FDA cited serious violations of the low-acid canned food regulations (LACF) and the seafood Hazard Analysis and Critical Control Point (HAACP) regulation at the low acid canned seafood processor’s facility in Pomorskie, Poland.
According to the warning letter, an inspection of the facility from March 6-7, showed the company’s canned seafood products are adulterated in that they have been prepared, packed or held under conditions whereby they may have been rendered injurious to health.
Under LACF regulations, the firm failed to meet the filed minimum processing temperatures and times for their production of “Salmon Salad in Tomato Sauce with Vegetables” and “Tuna Salad in Tomato Sauce with Vegetables.”
Regarding HAACP regulation, FDA noted that, “a food safety hazard is defined as ‘any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.’ ”
However, the firm’s HACCP plan for canned seafood products does not list the food safety hazard of scombrotoxin (histamine) formation associated with their mackerel, herring, and sprat, and undeclared allergens.
According to the warning letter, the firm must conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur.
Nautical Foods LLC Secaucus, New Jersey
In an Aug. 24 warning letter to owner and COO Steven Tucker, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations, and determined that the firms ready-to-eat (RTE) seafood products are adulterated in that they were prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.
During the inspection, the FDA collected environmental samples consisting of multiple swabs taken from various areas in the facility, “including areas where cross-contamination to food and food contact surfaces is possible.” According to the warning letter, FDA laboratory analysis of the environmental swabs identified the presence of Listeria monocytogenes in the facility.
The FDA’s laboratory analysis of environmental sample collected on March 1 confirmed that five environmental swabs tested positive for Listeria monocytogenes. The positive swabs were collected from surface areas in locations where ready-to-eat seafood salads are manufactured and packaged.
Specifically, three of these swabs were collected from the packaging area and two were collected from the ready-to-eat kitchen. These areas are in close proximity to food contact surfaces allowing for potential cross-contamination of food contact surfaces and food through the actions of man or machine.
“The presence of a resident strain of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.”
The FDA noted the following observations regarding seafood HACCP violations:
- The firm’s HACCP plan for “Crab Cake & Crab Cake Mix” does not list a critical control point for the use of time temperature indicators to control Clostridium botulinum growth and toxin formation in their refrigerated vacuum packaged finished products.
- The firm’s HACCP plans for “Crab Cake & Crab Cake Mix”, “RTC Frozen Product other than Crab Cake” and “RTE Seafood Salad” list a critical limit at the labeling critical control point that is not adequate to control for the hazard of undeclared allergens and sulfites.
- Additionally, the labeling critical limit in your firm ‘s HACCP plan for “RTC Frozen Product other than Crab Cake” is not adequate to control for the hazard of C. botulinum growth and toxin formation.
- The firm does not list an adequate monitoring frequency for their “RTE Seafood Salad”, failing to provide a food safety assurance equivalent to a continuous temperature recording device.
Additionally, the FDA reminded the processor that the FDA recommends that all finished product labeling accurately list all identified major food allergens of milk, egg, fish, crustacean shellfish, tree nuts, peanut, wheat and soybeans and sulfating agents that have a functional effect which are included in the product formulation.
Rozzo& Sons, Inc. New York, NY
In an Aug. 21 warning letter to president and co-owner Louis Rozzo, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HAACP) regulation, and the Current Good Manufacturing Practice regulation.
The FDA discovered and documented problems at the New York City seafood processing and distribution establishment June 20, 22 and 29, that rendered their fresh yellowfin tuna loins, refrigerated ready-to-eat vacuum packed cold smoked salmon and refrigerated ready-to-eat pasteurized crabmeat are adulterated, in that they have been prepared, packed, or held under conditions injurious to health.
The warning letter included the following significant deviations:
- Failure to monitor or have records to show that the products were not temperature abused during transit and have no controls in place for the receipt of products.
- Multiple products are not stored on ice and the firm does not have continuous monitoring of the temperature in their walk in cooler where the product is stored.
“You do not have continuous monitoring of the temperature in your walk in cooler where the product is processed (trimmed/filleted/packed) and you do not conduct any ice checks for histamine fish that are stored on ice,” according to the warning letter.
- Failure to monitor the condition and cleanliness of food contact surfaces, prevent cross-contamination from insanitary objects, ensure the maintenance of hand washing, hand sanitizing, and toilet facilities, or ensure the protection of food, and food contact surfaces from adulteration.
- Condensate drip was observed from a soiled green rag hanging on a pipe connected to the condenser fan and dripping directly onto a pile of exposed black sea bass stored on the fish descaling production table in the processing room.
- Open and exposed containers with black seabass were stored directly on the wet processing room floor after they were previously scaled, cleaned, and ready for sale.
- An employee was observed throwing small buckets of water onto black sea bass on the fish descaling production table above the open and exposed containers of black sea bass stored on the floor which then caused the water to splash onto the floor and then directly onto the product.
- The red shovel used to scoop ice from the ice machine was stored directly on the wet floor in front of the ice machine. The ice is used to cover exposed fish during storage and distribution.
- Ice used to cover the fresh fish during storage and transportation was observed stored directly touching the floor of the facility and directly touching the wheels of a trash bin that is wheeled inside and outside of the facility.
- Condensate drip was observed from a condenser fan on the ceiling of the processing room and directly dripping onto the scaling and fish cleaning table where exposed fish are descaled.
- Heavy accumulation of fish debris was observed in an open crevice on the wall to the right of the fish descaling table in the fish processing room.
- An employee’s glass beverage bottle was observed on a shelf directly above exposed fish that were being cut and processed in the processing room.
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