FDA WARNING_LETTER - Hai Nam Co., Ltd.

This Warning Letter from the FDA to Hai Nam Co., Ltd. identifies serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their scombrotoxin (histamine) forming fish adulterated.

Key deficiencies in their revised HACCP plan for mahi-mahi include: 1. **Inadequate Critical Limits (21 CFR 123.6(c)(3))**: * At "Receiving Raw Material," the plan lacks critical limits for handling practices onboard harvest vessels (e.g., histamine testing or vessel records) and for products transported from the wharf (e.g., continuous temperature monitoring or adequate ice). A one-time temperature check for extended transit is insufficient. * At "Filleting" and "Processing," the plan lacks adequate critical limits to control histamine formation, specifically regarding cumulative exposure times during unrefrigerated steps.

2. **Inappropriate Corrective Actions (21 CFR 123.7(b))**: * For "Receiving Raw Material," "Filleting," and "Processing," corrective actions involving histamine testing lack specificity on the number of fish to be sampled (FDA recommends 60 fish and destruction/diversion of the lot if any fish exceed 50 ppm). * Corrective actions for "Filleting" and "Processing" do not address the cause of