Rojas, Inc. – FDA Warning Letter, Aug 12, 2011

On November 15, 2011, the FDA issued a Warning Letter to Rojas, Inc. following an inspection of their seafood repackaging facility from August 9-12, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their dried shrimp products adulterated.

Key violations include: 1. **Lack of HACCP Plan:** Rojas, Inc. failed to implement a HACCP plan for dried shrimp products to control the food safety hazard of undeclared sulfites. FDA analysis found 352-375 ppm of sulfites in ground shrimp and 142-155 ppm in peeled shrimp. 2. **Lack of Sanitation Control Records:** The firm did not maintain records for monitoring sanitation conditions and practices, including water safety, food contact surface cleanliness, cross-contamination prevention, handwashing, protection of food/packaging, toxic chemical control, employee health, and pest exclusion.

Additionally, several misbranding violations were identified for their retail shrimp products (ground, peeled, whole): 3. **Undeclared Ingredients:** Labels failed to declare all ingredients, specifically salt and sulfiting agents (e.g., sodium metabisulfite or sulfur dioxide), despite their presence. 4. **Missing Nutrition Facts:** Products lacked required nutrition facts information. 5.