FDA WARNING_LETTER - H & H Seafood - July 07, 2015

The FDA inspected H & H Seafood from June 3 to July 7, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As a result, the firm's pasteurized canned crabmeat, ready-to-eat crabmeat, and tuna products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to list critical limits in HACCP plans for controlling pathogenic bacteria, Clostridium botulinum, and scombrotoxin formation at storage critical control points (21 CFR 123.6(c)(3)). Corrective action plans were deemed inappropriate as they did not include evaluating total time and temperature exposure when critical limits were exceeded (21 CFR 123.7(b)). The firm also failed to implement listed monitoring procedures and frequencies, evidenced by missing cooler temperature records and not changing temperature-recording charts as required (21 CFR 123.6(b) and (c)(4)). Additionally, H & H Seafood did not verify its HACCP plan's adequacy or effective implementation, as process monitoring instruments were not calibrated, and critical control point monitoring records were not signed and dated (21 CFR 123.8(a)(2)). Finally, HACCP plans lacked identification of what is monitored at each critical control point and a recordkeeping system for documenting monitoring (21 CFR 123.6(c)(4) and 123.6(c)(7)). The FDA noted a significant history of violations. The firm must respond within 15 working days with specific corrective actions, including an updated HACCP plan, monitoring records, and calibration records, to avoid further action such as product seizure or injunction. Re-inspection fees may also be assessed.