FDA Warning Letters: CA Seafood Processor/Importer and NY Dairy

The most recently posted warning letters from the U.S. Food and Drug Administration (FDA) include an exchange with a seafood processing and importing establishment in Rancho Dominguez, CA.

In a Sept. 8 warning letter, FDA told Central Boeki California Ltd. that during an inspection from June 12-15, 2015, the agency found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation and the Current Good Manufacturing Practice regulation for foods.

Failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with these regulations renders the fish or fishery products adulterated, FDA’s letter stated.

These issues were not adequately addressed in the company’s July 7 letter to FDA, the agency added. Among the issues that the seafood processor/importer must resolve are:

• Completion of a “hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. FDA found the company does not have HACCP plans for refrigerated Baked Sardines, refrigerated Baked Goby, and refrigerated Fish Sausage to control the food safety hazards of pathogen growth and toxin formation. Inspectors also found Baked Sardines and Baked Goby, labeled as “KEEP REFRIGERATED,” were being stored in your ambient temperature warehouse.”
• “Records must be kept for sanitation controls, including document monitoring and corrections.” FDA stated that it found no records for maintenance of hand-washing, hand sanitizing, and toilet facilities; protection of food, food packaging materials, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; and exclusion of pests, which are required for the processing (holding) of refrigerated Baked Sardines, Baked Goby and Fish Sausage, and frozen Jack Mackerel.
• “Written verification procedures must be implemented for product specifications as an affirmative step for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2).” FDA also said the company does not have documentation for Fish Sausage imported from Japan.

FDA’s letter stated that the company’s “refrigerated Baked Sardines, Baked Goby and Fish Sausage and frozen Jack Mackerel are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.” The agency asked for further written response from the company within 15 working days.

FDA also sent a warning letter dated Sept. 16, 2015, to the Richard W. Weaver dairy operation in Deansboro, NY, stating that a dairy cow sent to slaughter for food was found to have drug residues at levels much higher than allowed. The letter stated that the dairy operation was holding animals “under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”

FDA also stated that the dairy was failing to maintain treatment records and was not keeping treated animals segregated.

Drug residue levels for the animal antibiotics desfuroylceftiofur and flunixin were excessive, the agency noted. By exceeding drug residue levels, food from such animals is by definition adulterated and unfit for human consumption.

Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

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