FDA WARNING_LETTER - Day Boat Seafood LLC - January 19, 2011

An FDA inspection of Day Boat Seafood, LLC, conducted in December 2010 and January 2011, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Consequently, the firm's Barracuda, Grouper, Mackerel, Mahi Mahi, Triggerfish, and Wahoo products are deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations include the failure to establish adequate critical limits in HACCP plans for histamine formation (21 CFR 123.6(c)(3)), specifically regarding sensory evaluation values and vessel cooling conditions. The firm also failed to implement monitoring procedures as listed in its HACCP plan (21 CFR 123.6(b) and (c)(4)), such as obtaining captain/dealer declarations for Ciguatera, recording internal fish temperatures, and documenting cooler temperatures. Additionally, the corrective actions outlined in the HACCP plan were found to be inappropriate (21 CFR 123.7(b)), lacking steps like discontinuing suppliers, performing sensory exams on all fish, or identifying and repairing cooler issues. The FDA requires a written response within fifteen working days detailing specific corrective actions, including supporting documentation. Failure to promptly correct these violations may result in further action, including product seizure and injunction against the firm's operations.