The U.S. Food and Drug Administration (FDA) issued warning letters to two seafood companies, citing health and safety violations of varying degree and scope.
One of the companies that received a letter, Pescatlantic Inc., was called out for “serious violations” of federal seafood HACCP (Hazard Analysis and Critical Control Points) regulations in its importing facility at 6100 Blue Lagoon Dr. in Miami, Florida reported Food Safety News. An inspection on 10 to 11 May found that the company possessed “no written verification procedures or product specifications” and did not maintain a HACCP plan affirmative step for its imported fresh yellowfin tuna.
“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, dated 14 June, stated.
The agency said it may take further action if the violations are not remedied, including refusing admission of fish or fishery products to the U.S., placing them on “detention without physical examination,” seizing the products and enjoining the firm from further violation of the law.
Gasco Industrial Corp. also received a letter from the FDA, dated 11 February, warning the company after the agency uncovered a series of violations of Current Good Manufacturing Practices (CGMPs) in manufacturing, packing or holding human food at a manufacturing facility in Gurabo, Puerto Rico.
FDA inspected the Gasco facility on 9, 13, and 22 October, 2015, and listed some observations on a form given to company representatives, who vowed to make corrections.
“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.
Among the violations observed by the agency were “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,” noted the agency.
Moreover, “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,” detailed the FDA. “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 said.
The Gasco facility also failed to clean and sanitize utensils and equipment, making them susceptible agents of food contamination, and hand-cleaning stations were found without soap and overhead lights lacked protective covers.
“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,” the agency concluded in its letter.
