FDA WARNING_LETTER - Irvington Seafood Inc. - September 27, 2013

The FDA inspected Sakprasit Enterprises Inc. DBA Irvington Seafood Inc. in Irvington, Alabama, on August 12, 13, and September 27, 2013, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). Consequently, the firm's cooked, fresh picked, ready-to-eat crabmeat products are deemed adulterated under 21 USC 342(a)(4) due to insanitary conditions. Specific violations include the failure to take corrective action when a critical limit deviation occurred for pathogen survival (21 CFR 123.7(a)), failure to implement the HACCP plan's record-keeping system by not recording monitoring observations (21 CFR 123.6(b)), and failure to adequately monitor sanitation conditions, particularly pest exclusion and cleanliness of food contact surfaces (21 CFR 123.11(b)). Evidence included live flies in processing areas and unsanitary etched knives. The firm must respond in writing within 15 working days, detailing specific corrective actions with supporting documentation. Failure to comply may result in product seizure, injunction, and re-inspection fees.