FDA WARNING_LETTER - Millington Seafood LLC - August 29, 2012

On October 3, 2012, the FDA issued a Warning Letter to Millington Seafood, LLC, following an inspection from August 22, 27, and 29, 2012, at their facility in Millington, MD. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their histamine and non-histamine forming finfish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: - Lack of a written HACCP plan for histamine and non-histamine forming (b)(4) [21 CFR 123.6(b)]. - HACCP plan for (b)(4) does not list associated food safety hazards [21 CFR 123.6(c)(1)]. - HACCP plan for (b)(4) lists a critical limit insufficient to control hazards [21 CFR 123.6(c)(3)]. - Failure to review critical control point monitoring records for (b)(4) within one week [21 CFR 123.8(a)(3)]. - Insufficient frequency in monitoring sanitation conditions and practices to ensure CGMPs [21 CFR 123.44(b)]. - Failure to maintain sanitation control records