The most recently posted warning letters from the U.S. Food and Drug Administration went to a seafood importer in Miami and a food manufacturing facility in Puerto Rico. The letters were sent in February and June but just recently made public. FDA’s Florida District Office told Pescatlantic Inc. in a June 14 warning letter that a May 10 and 11 inspection of the company’s seafood importing facility at 6100 Blue Lagoon Dr. in Miami revealed “serious violations” of federal seafood HACCP (Hazard Analysis and Critical Control Points) regulations. The agency stated that the firm has “no written verification procedures or product specifications” and did not maintain a HACCP plan, nor implement an affirmative step, for its imported fresh yellow fin tuna. Seafood importers must also have a written guarantee from foreign processors that the imported fish or fishery product is processed in accordance with U.S. seafood HACCP regulations, the letter stated. “Because our inspection identified serious violations for 21 CFR Part 123, your fresh yellow fin tuna is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health,” FDA letter stated. The agency may take further action unless these violations are corrected, the warning letter added, including refusing admission of fish or fishery products to the U.S., placing them on “detention without physical examination,” seizing the product(s) and/or enjoining the firm from further violation of the law. On Feb. 11 FDA’s San Juan District Office sent a warning letter to Gasco Industrial Corp. stating that inspectors had observed numerous violations of Current Good Manufacturing Practices (CGMPs) in manufacturing, packing or holding human food during an inspection of the company’s food manufacturing facility in Gurabo, Puerto Rico, on Oct. 9, 13, and 22, 2015. The observations were detailed on a form later issued to the company by the agency, the February letter pointed out. “At the end of the inspection, you promised to make corrections; however, to date we have not received a response with corrections from your firm,” FDA wrote. Specifically, inspectors found “what appears to be live cockroaches, too numerous to count, coming from a wooden pallet” next to equipment used to manufacture seasonings. “The cockroaches scattered throughout the seasonings production room as the pallet was moved. In addition, a live cockroach was observed in the hand-washing station in the women’s toilet facility,” the agency stated. “Also, gaps to the exterior premises were observed throughout the facility, as well as missing, damaged and/or detached windows screens which facilitate entry of pests. We are concerned with your continued inability to take effective measures to exclude pests. This is a repeat observation disclosed during previous U.S. FDA inspections” in 2010, 2011 and 2012, the warning letter continued. Inspectors also noted failure to clean and sanitize utensils and equipment to protect against contamination of food and food-contact surfaces, as required by law. This problem was also observed during previous inspections, FDA’s letter stated. Additional problems included lack soap at hand-washing stations and no protective covers on lighting fixtures suspended over exposed food. “This letter may not list all the violations at your facility,” FDA concluded. “You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.” Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
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