FDA WARNING_LETTER - Valley Wholesale Produce and Seafood - March 24, 2011

On March 18 and 24, 2011, the FDA inspected Valley Wholesale Produce and Seafood's warehouse in Winchester, VA, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's canned pasteurized crabmeat was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to preparation, packing, or holding under insanitary conditions.

The primary violation was the firm's failure to have a written HACCP plan for canned pasteurized crabmeat to control the food safety hazard of pathogens, including Clostridium botulinum, from time/temperature abuse, as required by 21 CFR 123.6(a) and (b). Additionally, the firm lacked a HACCP plan for cooked shrimp to control pathogen hazards.

Furthermore, Valley Wholesale Produce and Seafood failed to register its facility with the FDA, a requirement under Section 415 of the Act and 21 CFR Part 1, Subpart H. Failure to register is a prohibited act under Section 301(dd) of the Act.

The FDA warned that failure to promptly correct these violations could lead to further action, including product seizure and/or injunction against the firm's operation. The company was required to respond in writing within fifteen working days, outlining