FDA WARNING_LETTER - Merchants Market St. Croix LLC - November 15, 2018

The FDA inspected Merchants Market St. Croix, LLC's seafood warehouse and distribution facility from November 13-15, 2018, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, their pasteurized canned crabmeat product is considered adulterated. Key deficiencies include the firm's failure to have a written HACCP plan for refrigerated pasteurized canned crabmeat to control Clostridium botulinum toxin formation and pathogenic bacteria growth due to temperature abuse, as required by 21 CFR 123.6(a) and (b). The firm's written response to the inspection was deemed inadequate, lacking an implementation date for a proposed HACCP plan, and their proposed mitigation of freezing upon receipt would not control hazards during transit. Furthermore, no records were provided to demonstrate the successful implementation of a transit temperature monitoring SOP, and the proposed 90-day record retention timeframe was not compliant with 21 CFR 123.9. Merchants Market St. Croix, LLC must respond within fifteen working days, detailing specific corrective actions, including an implemented HACCP plan and five consecutive days of temperature monitoring records. Failure to promptly correct these violations may result in FDA regulatory actions such as seizure or injunction, and the assessment of re-inspection fees.