Keyser Brothers Incorporated – FDA Warning Letter, Aug 13, 2013

On October 25, 2013, the FDA issued a Warning Letter to Keyser Brothers Incorporated following an inspection from July 29 to August 13, 2013, at their seafood processing facility in Lottsburg, VA. The inspection revealed serious deviations from the seafood Hazard Analysis and Critical Control Points (HHACCP) Regulations (21 CFR Part 123), rendering their fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to monitor sanitation conditions (21 CFR 123.11(b)):** * **Employee health:** Employees handled ready-to-eat crabmeat with bandages, rings, nail polish, and wristwatches, and one touched shoes then resumed handling crabmeat without washing hands. * **Pest exclusion:** The crab cooking area was open to the outside, with numerous flies observed on equipment, Mr. Keyser, and crab products. A 4x5 inch gap in plastic strip curtains between the picking and cooking areas allowed outside access. 2. **Inadequate HACCP plan monitoring procedures (21 CFR 123.6(c)(4)):** * HACCP plans for "Fresh Crabmeat: non-hermetic cups" and "Blue Crab" had non-