Venus Foods Inc – FDA Warning Letter, Sep 23, 2009

On January 25, 2010, the FDA issued a Warning Letter to Venus Foods, Inc. following an inspection from September 10-23, 2009. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

Specifically, the company's Shrimp-Flavored Fish Ball and Cuttlefish Ball products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. The Venus Shrimp Flavored Fish Balls and Wei-Chuan Shrimp Flavored Fish Balls were also misbranded under Sections 403(a)(1), 403(i)(2), and 403(q)(1)(a)(i) of the Act.

Key violations included: 1. **HACCP Implementation:** Failure to implement listed monitoring procedures for cooler air temperature at the "Refrigerated storage of finished product CCP4BCT" critical control point, specifically, the continuous chart recorder was not in operation. The company's response regarding "twice daily" monitoring was unclear and did not confirm the continuous monitoring equipment's functionality. 2. **Misbranding - False or Misleading Labeling:**