FDA WARNING_LETTER - Sherwood Food Distributors, LLC - October 20, 2014

On November 19, 2014, the FDA issued a Warning Letter to Sherwood Food Distributors, LLC following an inspection from October 15-20, 2014, at their Detroit, MI facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

Specifically, the firm's ready-to-eat pasteurized vacuum-packed imitation crab and lobster meat were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), due to being prepared, packed, or held under conditions that may render them injurious to health.

Two significant deviations were identified: 1. Failure to implement a written HACCP plan to control the food safety hazard of *Clostridium Botulinum* growth associated with reduced oxygen packaging (vacuum-packed imitation crab and lobster meat), as required by 21 CFR 123.6(b). 2. Failure to maintain sanitation control records documenting monitoring and corrections, as required by 21 CFR 123.11(c).

Sherwood Food Distributors, LLC was required to respond in writing within 15 working days, outlining specific corrective steps, including documentation such as a revised HACCP plan and five consecutive days of completed monitoring records. Failure to correct violations may result in FDA assessing fees for