The most recent batch of posted warning letters from the U.S. Food and Drug Administration went to a New York seafood importer, an acidified foods processor in Vermont, a dairy farm in Wisconsin, an Iowa soybean storage facility and a seafood processor in Brazil. FDA WarningIn an April 21 warning letter, FDA told CK Frozen Fish and Food Inc. that agency inspectors had found “serious violations” of the federal seafood HACCP regulations during a Jan. 6, 2016, visit to the company’s seafood importing facility in Jamaica, NY. Specifically, FDA stated that the company must implement an affirmative step for Frozen Dry Keski (a tiny fish often used in curry dishes). FDA’s April 21 letter to Constantine Poulos and Company, dba International Foods, in Burlington, VT, noted that an inspection done on Feb. 1, 8 and 11, 2016, of the company’s processing plant in Williston, VT, revealed problems during the manufacture of its acidified pepperoncini products. Inspectors found that “your firm drains bulk pepperoncini, repacks the drained pepperoncini by hand into one gallon plastic jars, and then you top each jar with a new water and vinegar solution,” the letter stated. Other issues cited involved insufficient efforts to minimize contamination, maintain cleanliness, and adequately test and record pH values. Rindt’s Wolf River Dairy of Shawano, WI, was told in an April 21 warning letter that unacceptably high drug residues had been found in a dairy cow sold for slaughter as food on or about Sept. 24, 2015. Tissue samples collected from the animal found 0.06 parts per million (ppm) of ampicillin and also the presence of tulathromycin in the kidney tissue, the agency noted. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissue of cattle and a tolerance of 5.5 ppm for residues of tulathromycin in the edible liver tissue of cattle. However, there is no approved use of tulathromycin in female dairy cattle 20 months of age or older, the letter stated. “(S)ignificant deviations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food” were found by FDA inspectors during a March 17-22, 2016, visit to Lee Seed Company Inc. in Inwood, IA, according to a warning letter dated April 14. FDA listed nine specific CGMP violations involving the processing and packing of soybeans, specifically noting that “manufacturing equipment for processing soybeans (roasters) are not cleaned and emptied properly since at least 2014, uncovered manufacturing equipment located near rodent and insect activity, and raw soybeans open to an insanitary surrounding environment,” the letter stated. The Iowa company was told that effective measures needed to be taken to exclude pests from the facility’s processing areas and protect against the contamination of soybeans on the premises by pests. For example, FDA inspectors noted dead mice near the manufacturing equipment where roasted soybeans were stored, rodent excreta around boxes of wheat in storage areas, and rodent pellets on shelving units in packaging areas. Inadequate hand-washing, hair coverings and facility lighting were also observed, FDA’s letter stated. Atum Do Brasil Captura Industria e Comercio of Itapemirim, Brazil, was sent a warning letter on March 18 noting that serious seafood HACCP violations had prompted a finding that the company’s fresh whole fish, fresh gutted fish, and fresh fish filets are adulterated. FDA’s letter pointed out that the company needed to conduct, or have conducted, a hazard analysis and seafood HACCP plan listing potential food safety hazards, including that of Clostridium botulinum toxin formation and critical control points for controlling scombrotoxin (histamine) formation. Further, FDA stated that temperature monitoring was needed onboard harvesting vessels and during transit to the processing plant so that the internal temperature of fish at the time of delivery does not exceed 40 degrees F. Should the company not respond, or the response be found inadequate, the agency’s letter stated that the agency may refuse admission to the U.S. of its imported fish or fishery products, including placing them on detention without physical examination upon entry. 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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