FDA WARNING_LETTER - Preferred Freezer Services Of Atlanta, LLC - July 08, 2015

On July 2-8, 2015, the FDA inspected Preferred Freezer Services of Atlanta, LLC, a seafood processing facility, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's frozen shrimp, which are repacked, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation was the firm's failure to conduct a hazard analysis and implement a written HACCP plan to control the food safety hazard of undeclared sulfiting agents in repacked frozen shrimp, as required by 21 CFR 123.6(a) and (b). The firm's operation of opening and repacking frozen shrimp constitutes "processing." The submitted HACCP plan was deemed inadequate as it did not address undeclared sulfiting agents and appeared to only cover repacking without opening individual packages.

Additionally, the firm failed to adequately monitor and document sanitation conditions and practices, violating 21 CFR 123.11(b). Specifically, sanitation monitoring records for February 23-27, 2015, were not documented, and some information on records, such as personnel initials and time, was routinely pre-filled, not