The U.S. Food and Drug Administration (FDA) posted several recent warning letters about alleged regulation violations, including those sent to food manufacturers in Nebraska and Washington, seafood processors in Massachusetts, Maine and Michigan, and farms in New York and Kentucky. IPSI Specialty Foods Inc. of La Vista, NE, which pickles chicken eggs, was told by FDA that it needed to register as a commercial processor of acidified foods, file information on how it does heat processing and control pH, salt, sugar, and preservative levels, and improve certain plant conditions such as cleanliness and lighting. FDA informed G. Wolf Enterprises Inc. of Gold Bar, WA, that it needed to file scheduled processes for the production of 17 acidified foods (pickles, cucumbers, asparagus, garlic, and cilantro chutney) and to examine glass jars often enough for potential leakage or food contamination. The agency also asserted violations of seafood HACCP regulations, given that the company’s spice condiment product contains shrimp, and the letter stated that inspectors had observed problems involving cleanliness and storage practices at the manufacturing facility. M & B Sea Products Inc. of New Bedford, MA, was visited by FDA inspectors in July and August, who noted that the company needed a seafood HACCP plan and better temperature controls and monitoring practices to help make sure that its raw, unpreserved scallops did not develop Clostridium botulinum. FDA told Seaview Fisheries Inc. (doing business as Seaview Lobster Co.) of Kittery, ME, that it needed to demonstrate that the cooking critical limit for lobster was sufficient to control a pathogen hazard. In addition, FDA stated that sanitation conditions and practices during processing needed to be monitored more often to prevent cross-contamination.

Michigan Brands Inc. of Bay City, MI, was inspected in June and July and found to be lacking a sufficient seafood HACCP plan. FDA specifically stated that the firm needed a hazard analysis for smoked alligator and salmon smoked strips so that Clostridium botulinum, pathogenic bacteria growth and toxin formation, and allergens could be adequately controlled. Monitoring and record-keeping practices also needed to be implemented, FDA stated. Ashland Farm LLC of Aurora, NY, allegedly violated Federal Food, Drug, and Cosmetic Act when it sold for slaughter a bob veal calf which was later found to have gamithromycin in its kidney tissues. FDA has not established a tolerance for residues of gamithromycin in the edible tissues of calves intended for slaughter as veal, the agency noted. Further, the drug was not used as directed by its approved labeling and was not administered under the supervision of a licensed veterinarian, FDA stated. In FDA’s warning letter to Hoover Family Farm of Scottsville, KY, the agency stated that, after an inspection in June, it found that a calf had been sold for slaughter which was found to have 0.072 parts per million (ppm) of penicillin in its kidney tissue. However, FDA has established a tolerance of 0.05 ppm for residues of penicillin in the kidney tissue of cattle. In each warning letter, FDA requested that the farms and companies provide written responses detailing steps taken to bring them into compliance with food safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. Recipients of the warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.