FDA WARNING_LETTER - Seafood Supply Company, Lp - June 22, 2012
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On June 14-22, 2012, the FDA inspected Seafood Supply Company, LP, in Dallas, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's fresh processed fish (e.g., salmon, tuna) and packaged seafood (e.g., pasteurized canned crabmeat) adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.
Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for Fresh Processed Fish; Non-Scombroid Species (including salmon) fails to list parasites and pathogen growth/toxin formation as hazards for fish intended for raw consumption. Additionally, the firm improperly grouped products with different food safety hazards in their HACCP plans. A November 19, 2012, response was deemed inadequate for failing to address hazards or provide revised plans. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** * The HACCP plan for Fresh Processed Fish; Scombroid Species lists a receiving CCP critical limit
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