FDA WARNING_LETTER - Rico Brand - June 10, 2010

The FDA inspected Fierro Group dba Rico Brand's seafood processing facility in Salt Lake City, Utah, on June 7-8, 10, 2010. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulation (21 CFR Part 110). Specifically, the firm's shrimp ceviche was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included the failure to conduct a hazard analysis and implement a written HACCP plan for shrimp ceviche to control pathogen growth and toxin formation (21 CFR 123.6(a) and (b)). Additionally, the firm failed to maintain sanitation control records documenting monitoring and corrections for critical areas like water safety, cross-contamination prevention, and handwashing facilities (21 CFR 123.11(c)). The firm also did not monitor sanitation conditions and practices with sufficient frequency to ensure compliance with GMP requirements (21 CFR 123.11(b)), with examples cited including improper towel sanitization, employees returning to processing without handwashing, product contact with employee smocks, lack of sanitizer concentration, unlabeled chemical bottles, and pest entry points.

The FDA requires a written response within fifteen working days outlining specific corrective actions, including documentation like HACCP plans and sanitation monitoring records. Failure to correct these violations could lead to further regulatory action, such as product seizure or injunction. The firm is responsible for ensuring overall compliance with all applicable regulations.