A sandwich, wrap and flatbread manufacturing facility and two seafood importers are on notice from the Food and Drug Administration for violations of the federal Food, Drug and Cosmetic Act.

The FDA warned one company in March, and the other two in May. The warning letters were just recently posted for public view. The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations.

SK Food Group Inc.
In a March 13 warning letter to Jakob Loseke, vice president of U.S. operations and plant manager of the SK Food Group facility in Reno, NV, the FDA described the company’s serious violations of the Current Good Manufacturing Practices (CGMPs). FDA inspectors collected environmental samples in the processing facility.

“FDA laboratory analysis of the environmental samples identified the presence of Listeria monocytogenes, a human pathogen in your facility,” according to the warning letter.

The insanitary conditions rendered the ready-to-eat (RTE) sandwich, wrap and flatbread products injurious to human health. The FDA noted that two environmental swabs were collected from locations that were in areas adjacent to food contact surfaces.

Similarly the report noted, “six swabs with non-pathogenic Listeria species including Listeria innocua, Listeria seeligeri and Listeria welshimeri. These positive swabs were found on non-food contact surfaces including the floor in the dishwashing and Mezzanine Rooms and on direct food contact surfaces, like the conveyer belt, wher you manufacture RTE food products. The presence of non-pathogenic Listeria species is indicative of insanitary conditions that are suitable for the survival and/or growth of the pathogen L. monocytogenes.”

Regarding Listeria, the inspector described in the warning letter that the pathogenic bacterium is “widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities wher it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness, which is a major public health concern, due to the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions.”

“Additionally, of concern during the inspection was the observation by the FDA investigators that firm failed to ensure that cleaning and sanitizing of utensils and equipment was conducted in a manner that protected against contamination of food, food-contact surfaces, or food- packaging materials.”

These significant observations demonstrated that the company’s sanitation efforts are inadequate to effectively control pathogens in their facility, generally and potentially on their processing equipment in order to prevent contamination of food.

A.I. Foods Corporation
In a May 23 warning letter to company president Clarissa Takawaka, the FDA described violations observed during an inspection on April 5 at the company’s facility that handles imported fish and fishery products.

The Los Angeles facility presented serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, according to the warning letter. Fish importers are required by federal law to comply with the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance Act, which includes taking effective measures to keep conditions sanitary.

The company did not have implemented written verification procedures, product specifications, or an affirmative step for its imports. The inspector specifically stated that the fish sauce and frozen plain deboned milkfish were, “prepared, packed, or held under insanitary conditions wherby they may have been rendered injurious to health.”

Harbor Marine Product Inc.
In a May 8 warning letter to Joon Kim, the FDA reported serious violations of the current  seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations. According to the warning letter, the company’s fresh flounder fish was prepared, packed or held under unsanitary conditions.

A March 21 inspection in Los Angeles showed that the company failed to provide evidence that all fish and fishery products offered for entry into the United States had been processed under conditions that comply with 21 CFR Part 123.

“If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.”

The inspector also noted that the FDA may refuse admission of the company’s imported fish or fishery products, if the company does not promptly correct the noted violations.