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Greenhead Lobster Products LLC, a ready-to-eat seafood processing facility in Maine, was cited for serious violations of the Seafood HACCP regulation (21 CFR Part 123) and insanitary conditions that rendered their cooked lobster products adulterated. FDA inspection conducted in September-October 2021 found Listeria monocytogenes, a human pathogen, present in environmental samples from food-contact surfaces and areas near processing operations. The facility's failure to have and implement a compliant HACCP plan meant their RTE lobster products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.