FDA WARNING_LETTER - Mexican Products & Spice Company - May 21, 2012

On June 26, 2012, the FDA issued a Warning Letter to Mexican Products and Spice Company following an inspection of their seafood processing facility in La Feria, Texas, from May 17-21, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The primary violation identified was the firm's failure to have and implement a written HACCP plan for repacked dried shrimp products to control the food safety hazard of undeclared sulfiting agents, specifically sodium bisulfite. Although the firm's current labels declare sulfites, there are no ongoing control measures in a HACCP plan to ensure these declarations consistently appear in labeling. This renders the shrimp products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under insanitary conditions.

The FDA acknowledged the firm's June 12, 2012, letter stating a hazard analysis was conducted and HACCP training was planned, but noted a HACCP plan had not yet been provided. Failure to promptly correct this violation may result in further action, including product seizure and/or injunction against the firm's operation. The letter also stated that FDA may assess fees for re-inspection-related costs. The company was required to respond in