FDA WARNING_LETTER - Hopkins, E Frank Co., Inc. - August 27, 2012

On September 18, 2012, the FDA issued a Warning Letter to Hopkins, E Frank Co., Inc. following an inspection from August 16-27, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110), rendering their fish and fishery products adulterated.

Key violations include: 1. **Sanitation Monitoring Deficiencies (21 CFR 123.11(b))**: Failure to adequately monitor food contact surfaces, prevent cross-contamination (e.g., histamine-forming fish water flowing into non-histamine fish, dirty pooled water on processing tables), and ensure proper employee hygiene (handwashing, glove changes, hand dip use). 2. **Inadequate HACCP Plan Critical Limits (21 CFR 123.6(c)(3))**: The HACCP plan for pasteurized, canned crabmeat had an insufficient critical limit for Clostridium botulinum at receiving, relying only on surface temperature without considering transit conditions. The firm also lacked temperature monitoring records for imported crabmeat. 3. **Inadequate HACCP Plan Monitoring Procedures/Frequency (21 CFR 123.6(c)(4))**: Monitoring procedures for pasteurized, canned crabmeat at receiving were inadequate