FDA WARNING_LETTER - Philippine Cinmic Industrial Corporation - April 21, 2012

On April 16, 2012, the FDA requested HACCP documentation from Philippine Cinmic Industrial Corp. for their fresh frozen tuna treated with carbon monoxide. A review of the submitted documents revealed serious deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123), rendering their product adulterated under 21 USC 342(a)(4).

Significant violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for fresh frozen tuna treated with CO failed to list appropriate critical control points (CCPs) for scombrotoxin formation and undeclared allergens. Specifically, it lacked a receiving CCP for fish off-loaded at the dock to control scombrotoxin, and a labeling CCP to ensure correct species declaration for allergen control. 2. **Inadequate Monitoring Procedures (21 CFR 123.6(c)(4)):** The plan listed inadequate monitoring procedures for the (b)(4) critical control point, lacking procedures for overnight storage in trucks. For the "Chilling" CCP, intermittent temperature checks during working hours were insufficient, with no monitoring for non-working periods like overnight or weekends. 3. **Inappropriate Corrective Action Plans (21 CFR 123.7(b)):**