Benz's Food Products Inc. – FDA Warning Letter, Oct 25, 2010

On October 21-25, 2010, the FDA inspected Benz's Food Products, Inc., finding serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their seafood, including ready-to-eat herring, adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits (21 CFR 123.6(c)(3)):** The plan for ready-to-eat salt-cured herring fillets in oil had inadequate critical limits for "Temperature at Receiving" and "Refrigerated Cold Storage" to control histamine and pathogen growth, including *C. botulinum*. Specifically, temperature limits were not stringent enough (e.g., 40°F upper limit recommended for receiving) and inappropriately included time limits as part of the critical limit rather than corrective action. 2. **Inadequate Monitoring Procedures (21 CFR 123.6(c)(4)):** The monitoring frequency at "Temperature at Receiving" was insufficient; continuous time-temperature recording devices with daily visual checks were recommended. 3. **Inappropriate Corrective Actions (21 CFR 123.7(b)):** Corrective actions for "Temperature at Receiving,"