FDA WARNING_LETTER - Whole Foods Market Denver Distribution Center - January 24, 2014

An FDA inspection of Whole Foods Market's Denver Distribution Center, a seafood processor, from January 14-24, 2014, revealed violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). The primary deficiency identified was the firm's failure to have and implement a written HACCP plan for scombroid/histamine forming species fish, including tuna, sardines, anchovy, mackerel, bluefish, mahi-mahi, and wahoo, to control the food safety hazard of histamine, as required by 21 CFR 123.6(a) and (b). This non-compliance renders the affected fish and fishery products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's February 7, 2014, response was deemed inadequate due to the absence of the required HACCP plan and supporting documentation. Whole Foods Market is required to respond within fifteen working days, detailing specific corrective actions, including submission of the HACCP plan and monitoring records. Failure to promptly correct these violations could lead to further regulatory action, such as product seizure or an injunction against the firm's operations. The letter emphasizes the firm's responsibility for overall compliance with all applicable regulations.