FDA WARNING_LETTER - Gropoint Seafood Industries Sdn Bhd

On July 27, 2010, the FDA issued a Warning Letter to GroPoint Fisheries SDN BHD in Labuan, Malaysia, following an evaluation of their HACCP plan and supporting documents for fish and fishery products. The FDA found serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their scombrotoxin-forming fish, such as tuna and Mahi Mahi, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis and CCPs:** The HACCP plan for scombrotoxin-forming fish failed to list a critical control point for overnight refrigerated storage during carbon monoxide treatment, which could lead to scombrotoxin and *Clostridium botulinum* formation. 2. **Insufficient Monitoring Procedures:** Monitoring procedures at the "Receiving at Dock" critical control point were inadequate. The firm relied on post-facto interviews with vessel operators regarding fish handling, which does not ensure critical limits are met or prevent receipt of time/temperature abused fish. Additionally, the required chilling temperature was incorrectly listed as (b)(4) instead of 4.4°C or below. 3. **Inappropriate Corrective Actions:** Corrective actions at the "Plant Receiving and Wash Fish" critical control point were deemed inappropriate. The firm