FDA WARNING_LETTER - Topway Enterprises, Inc - November 04, 2011

On October 17, 2011, to November 4, 2011, the FDA inspected Topway Enterprises, Inc. d.b.a Kazy’s Gourmet, a seafood processing facility in Houston, Texas. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their Vacuum Packed Yellowtail (Hamachi) and Histamine Prone Fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Critical Limits:** The HACCP plan for Vacuum Packed Yellowtail (Hamachi) lacked a critical limit to ensure the product was maintained at or below 38°F during transit, which is crucial for controlling *Clostridium botulinum* and histamine formation. 2. **Insufficient Monitoring Procedures:** The monitoring procedure for Vacuum Packed Yellowtail (Hamachi) at the receiving critical control point was inadequate. It failed to specify how to monitor the quantity and frozen status of cooling media and the internal temperature of the fish upon delivery. 3. **Inappropriate Corrective Actions:** * For Vacuum Packed Yellowtail (Hamachi) cooler storage, the corrective actions for *Clostridium botulinum* did not address regaining control over the operation after a critical limit deviation. * For Fresh