FDA WARNING_LETTER - Vern's Cheese, Inc. - June 02, 2015

The FDA inspected Vern's Cheese, Inc. from May 20 to June 2, 2015, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their refrigerated, ready-to-eat seafood products, such as Herring Cutlets in Wine and Creamed Fillet of Herring, adulterated under 21 U.S.C. § 342(a)(4).

While the firm's June 9, 2015, response addressed some GMP observations, it failed to provide specific information on how continued seafood HACCP deviations would be addressed. Significant remaining deviations include:

1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for ready-to-eat fish products does not identify scombrotoxin (histamine) formation in herring, a scombroid species, or *Clostridium botulinum* growth and toxin formation in reduced-oxygen plastic containers. 2. **Inadequate Monitoring Procedures (21 CFR 123.6(c)(4)):** * **Temperature during storage:** The monitoring procedure for the "Temperature during storage" critical control point, relying on an alarm system and "visual check" once "per time period," is inadequate. It allows for