The Food and Drug Administration (“FDA”) issues Warning Letters to provide individuals and companies with an opportunity to take voluntary and prompt corrective actions for violations of regulatory significance that may otherwise lead to enforcement.

A Warning Letter is the FDA’s principal means of achieving prompt voluntary compliance with the Federal Food, Drug, and Cosmetic Act (FDCA).

Companies in receipt of a Warning Letter have 15 days to respond to the agency, in writing, to explain the steps taken to correct the violations.

The FDA then evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures.

Below is a brief synopsis of FDA’s food-related Warning Letters issued and posted between August 5, 2014 and September 5, 2014.

Warning Letters issued to six dairies

FDA issued Warning Letters to six dairies that sold adulterated animals for slaughter as food. Such food is deemed to be adulterated if 1) it bears or contains a new animal drug that is unsafe, and/or 2) the animal has been held under insanitary conditions. Failure to maintain complete treatment records presumes the food to be held under insanitary conditions.

The United States Department of Agriculture, Food Safety and Inspection Services (USDA/FSIS) examined tissue samples from the recipient dairies and found drug residue at each. These findings showed that the samples exceeded FDA’s acceptable drug residue levels and these dairies failed to maintain complete animal treatment records.

All six farms used drugs off-label. The off-label use of approved animal or human drugs in animals is allowed only if a licensed veterinarian within the context of a valid veterinarian-client/patient relationship prescribes it.

Further, appropriate measures must be taken to assure that assigned timeframes for withdrawal before marketing are met and no illegal drug residues occur in any food-producing animal subjected to the extra-label use. However, no record of supervision by a licensed veterinarian was found at any of the dairies.

Warning Letters issued to five seafood processing facilities

FDA issued Warning Letters to five seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Current Good Manufacturing Practice and Labeling Regulations.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan. The HACCP plan must contain the appropriate “critical limits,” which are measured and verified.

These would include, for example, temperature control measures that are monitored with calibrated instruments, a list of the food safety hazards of pathogens caused by time and temperature abuse, and undeclared allergens.

A food safety hazard is defined as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”  Moreover, any importer of seafood must have a written import verification procedure to ensure the imported fish and fishery products were processed in accordance with US standards.

Also, any exporters of seafood to the US must comply with the US Federal FDCA and all applicable federal regulations.

A seafood processing facility must also monitor sanitation conditions and practices during processing to ensure compliance with Current Good Manufacturing Practice Requirements.

This includes monitoring the condition and cleanliness of food contact surfaces and maintenance of hand washing and toilet facilities with sufficient frequency. One seafood processing facility was found not to clean or sanitize its trays used to process food before or after use, and there was no warm water available in the employee restroom.

Products must also be labeled correctly. Under the regulation, a product is misbranded when it contains an artificial flavoring, coloring or chemical preservative that the producers fail to include in its label.

One of the seafood processing facilities failed to include the color additives and sub-ingredients in the product’s label.

Warning Letters issued to two acidified foods processors

The FDA issued Warning Letters to two manufacturers of acidified foods for failure to schedule processes with FDA for foods produced, as required by the Acidified Food regulations.

Due to this violation, the agency found that products were adulterated. Scheduled process information for acidified or low-acid canned foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic).

More information on filing can be found in the publication “Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods.”

Additionally, the agency found one of the facilities did not have hot water at its hand-washing sink, the employees were not wearing hair nets while working with food and the facility lacked adequate lighting in areas where food was examined.

Further, one of these food processors did not comply with the seafood HACCP regulation to implement a written HACCP plan for its spice condiment that contains shrimp as a characterizing ingredient.

This processor also failed to conduct good manufacturing practices, including packaging and storage. The inspectors found conditions including mold and dust on piping above processing area as well as pooled liquid on the floors.

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