FDA WARNING_LETTER - B & F Fish Market Llc - June 23, 2011

On June 21 and 23, 2011, the FDA inspected B & F Fish Market, LLC in Parsons, Tennessee, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). These deficiencies render the firm's seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include failure to adequately monitor sanitation conditions, maintain sanitary building and physical facilities, and keep the plant and grounds clean to prevent contamination. The inspection also revealed unsuitable plant structures, inadequate cleaning of both food and non-food contact surfaces, and unsanitary restroom conditions. Furthermore, the firm failed to minimize odors and pest attractants from waste and did not handle work-in-process in a manner that protects against contamination. The FDA acknowledged some voluntary corrective actions, such as signing the HACCP plan and cleaning, but requires a written response within fifteen working days detailing specific corrective steps and supporting documentation. Failure to promptly correct all violations may lead to further legal actions, including product seizure or injunction, emphasizing the firm's responsibility to ensure full compliance with all applicable regulations.