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FDA issues warning letters to handlers of sprouts, fish products

A California sprout processor, a Denver fish processor and a New York seafood importer are all on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act. Two of the three facilities confirmed positive test results for Listeria, after environmental samples were taken during FDA inspection, and sent to laboratory analysis for pathogen testing.

The FDA sent the warning letters to the companies in May, June and August, 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.

Louie Foods International Fresno, CA
In an Aug. 21 warning letter to company owner and president Jay R. Louie, the FDA described violations observed during an inspection conducted from Feb. 13 to 28, 2017, at the Louie Foods International sprout operation and food processing facility. Environmental samples collected from the Fresno, CA, facility returned positive results during laboratory testing for Listeria monocytogenes (L. monocytogenes).

The company produces noodles and wonton wrappers, as well as alfalfa and mung sprout products at the facility, according to the warning letter.

The FDA collected swab samples of equipment and surfaces in the facility. Two such samples collected from the floor and the drain in the cooler were positive for Listeria monocytogenes, which is a human pathogen that can cause serious infections and death.

Inspectors observed violations of federal law that requires all people working in direct contact with food, food-contract surfaces and food-packaging materials to comply with current Good Manufacturing Practice (cGMP) Regulations.

The FDA inspector noted several significant violations, the first was for the following “Insanitary Conditions and Practices in the Sprout Operation.”

An employee used a high pressure spray hose to rinse trays used for alfalfa sprouts on the floor. Water was observed splashing off the floors and trays onto the bottom rack of alfalfa sprouts stored adjacent to the spray area.

“We note that pathogens such as Listeria monocytogenes that may be present on the floor may contaminate your alfalfa sprouts when aerosol from the floors lands on the product.”

Bins containing mung bean sprouts were stacked one on top of another so that sprouts were in direct contact with the bottom of the bin above them.

“Directly prior to stacking, the bottoms of the bins were observed coming into contact with a black plastic pallet that was soiled with dirty water and old wet mung bean seeds,” according to the warning letter.

On multiple occasions, employees were observed mixing and packaging sprouts with unwashed or unsanitized hands. Inspectors noted it was not possible for the employees to adequately wash their hands in the in the alfalfa sprout production room because the sink was not equipped with soap or paper towels.

“Employees touched insanitary objects such as street pants, control panels with build-up of debris, and a dirty spray hose that was dragging on the floor. The employees then resumed handling sprouts without first washing and sanitizing their hands. Soap, or some other surfactant, and adequate drying are essential for the removal of human pathogens from hands,” the warning letter states.

Investigators also observed problems in employee toilet facilities. One toilet facility lacked running water in the hand-washing sink, and the did not have toilet paper.

“A toilet contained fecal matter. The water from one hand sink was brownish and cold. We note, human feces are a known source of human pathogens and based on the lack of toilet paper in one toilet facility and the general lack of adequate hand washing facilities it is likely that your employees could not adequately wash the feces off their hands after using the toilet,” according to the the FDA warning letter.

The FDA also noted the following cGMP violations:

  • Apparent rodent excreta pellets, too numerous to count, were observed on a piece of unused equipment along the North East corner of the old tofu room approximately 5 feet away from the packaging area for noodles and wonton wrappers separated by an air curtain.
  • Apparent dead insects, too numerous to count, were observed on the floor along the North East corner of the old tofu room adjacent to the packaging area for the noodles and wonton wrappers separated by an air curtain.
  • A bird dropping was observed on the exterior surface of a folded cardboard box used to store packaged noodles. Three birds were observed flying over the boxes and perched above the noodle packaging.
  • Four employees with mustaches were not wearing facial coverings while in direct contact with noodle processing.
  • An employee was wearing an exposed bandage over a finger while directly handling processed noodles.

Etai’s Food Inc. Denver, CO
In a May 19 warning letter to co-owner Ehud Baron, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HAACP) regulation at the fish processor’s operation in Denver, CO. According to the warning letter, an inspection of the facility from Oct. 4 through Nov. 10, 2016, showed the company’s ready-to-eat (RTE) products 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 from various areas in the processing facility, including areas that are in close proximity to food and food contact surfaces.

“The FDA laboratory analyses of the environmental swabs identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility,” according to the warning letter.

Inspectors also reviewed product labeling and found violations of “the food labeling regulations 21 CFR Part 101” that cause the products to be misbranded.

In a response letter dated Dec. 9, 2016, company officials described various actions they had taken including retaining a consultant to advise them regarding environmental sanitation design, chemical treatment, and procedures; revising their cleaning and sanitizing programs; updating their SSOP; hiring a special crew of personnel to conduct the cleaning and sanitizing after production runs; and adding a cleaning verification step involving swabbing.

However, the FDA could not evaluate the adequacy of the firm’s response because it lacked “certain information, including a copy of your updated SSOP.” The FDA will assess the adequacy of the firm’s corrective actions during its next inspection.

The FDA noted the following specific violations during inspection:

  • Eight environmental swabs collected from various locations within your Salad Production Room and Packaging Room were positive for Listeria monocytogenes.
  • The firm does not have a HACCP plan for “Garden Salad with Seafood,” which uses a vacuum packaged imitation crab ingredient to control the food safety hazard of Clostridium botulinum, which causes botulism.
  • The firm does not have a HACCP plan for “Tuna Salad Sandwiches” in modified atmosphere packaging (MAP) to control the food safety hazard of biological pathogens growth and toxin formation, specifically Clostridium botulinum and Listeria monocytogenes.
  • The firm’s HACCP Plans for “Drained Tuna” used in cold salads and for the “Fully Cooked 2 oz. Salmon Fillets” for use on salads do not list the food safety hazard of undeclared allergens.
  • Labels on “Mixed Greens with Seafood” incorrectly declare “Shellfish (snow crab)” but the “Imitation Crab Meat” product information sheet provided by your supplier indicates that it does not contain crab.
  • The “Mixed Greens with Seafood Salad” label fails to declare all of the sub-ingredients of the multi-component ingredient “Imitation Crab Meat.
  • The “Tuna on Fire” product label fails to declare the sub-ingredients of the multi-component ingredients “bread,” “tomato salsa,” and “mayonnaise.” In addition, “Tongol Tuna” is not an appropriate common or usual name provided in the Seafood List for a type of tuna fish. If the fish is actually Thunnus tonggol, the acceptable common name or market name would be “longtail tuna” or “tuna.”

Seiki Co. Ltd. New York, NY
In a June 1 warning letter to company president Kenju Kuroiwa, the FDA described violations observed during an inspection on Dec. 19, 2016, at the importer’s processing facility.

According to the warning letter, the FDA collected HACCP plans entitled “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet),” which were both dated June 2, 2014. Both copies revealed serious deviations from the requirements of the seafood HACCP regulation.

The FDA reported the importer’s refrigerated and frozen vacuum packaged aquaculture yellowtail fillet are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

The following significant deviations include the following FDA observations:

  • The importers’s frozen aquacultured yellowtail is vacuum packaged, which generally reduces the amount of oxygen in a package and inhibits Clostridium botulinum. But the packaging should include handling instructions to state “Keep Frozen; Thaw Under Refrigeration Before Use” or similar language.
  • The importer failed to conduct, or have conducted for them, a hazard analysis for each kind of fish and fishery product it produces 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.
  • The method of storage and distribution listed in the heading of the importer’s HACCP plan is not adequate. Refrigerated vacuum and reduced oxygen packaged fresh fish must be continuously maintained at temperatures of 3.3 degrees C or below to prevent the hazard of Clostridium botulinum growth and toxin formation during all subsequent distribution until the individual packages are opened.
  • The importer’s HACCP plans for “Frozen Aquacultured Yellowtail Product Group (Fillet • Loin/Smoked)” and “Refrigerated Aquacultured Yellowtail (Fillet)”, both dated June 2, 2014, list critical limits that are not adequate to control the identified food safety hazards

“To adequately control the food safety hazard of scombrotoxin (histamine) formation that is reasonably likely to occur onboard the harvest vessel, FDA recommends you include critical limits for Harvest vessel records or Histamine testing, sensory examination, and internal temperature measurements at the time of off-loading from the harvest vessel by the processor,” according to the warning letter.

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