FDA WARNING_LETTER - Macduff Shellfish (Scotland) Ltd - December 06, 2019

On April 3, 2020, the FDA issued a Warning Letter to Macduff Shellfish (Scotland) Ltd following an inspection on December 5-6, 2019, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's ready-to-eat (RTE) frozen cooked rock crab and ready-to-cook frozen lobster products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for RTE frozen cooked rock crab did not list *Clostridium botulinum* toxin formation as a hazard, despite the product being in packaging conducive to its growth. The HACCP plan for ready-to-cook whole frozen lobster products failed to list undeclared major food allergens/intolerance substances (e.g., sulfites), which are used in processing. The firm's February 3, 2020 response was inadequate as it did not address these hazards in the HACCP plans. 2. **Failure to Take Appropriate Corrective Action:** The firm did not take corrective action when the "Whole Brown Crab – Cooked Frozen" process deviated from the critical limit for pathogenic bacteria control. A production record showed the internal temperature of a crab reached only (b