The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) seafood processing facility located at 122 Heritage Park Rd., Bucksport, ME 04416-4603, on September 21, 22, 23, 27, and 30, and October 6, 2021. During our inspection we collected environmental samples (i.e., swabs) from various areas in your facility, including areas that are near food during processing operations and your food-contact surfaces. FDA laboratory analyses of environmental samples found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA found serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 123 (21 CFR Part 123).
In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Based on our inspectional results, including review of FDA’s environmental testing and your HACCP plan, we have determined that your RTE cooked lobster products are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act, the seafood HACCP regulation, and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.External Link Disclaimer
At the conclusion of the inspection, the FDA investigators issued your facility a Form FDA 483, Inspectional Observations. You provided responses to the FDA Form 483 and FDA’s environmental sample findings via email on October 7 and 13, 2021, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your current HACCP programs as further described in this letter.