FDA WARNING_LETTER - Rainbow Export Processing S.A. - August 19, 2014

On August 18 and 19, 2014, the FDA inspected Rainbow Export Processing S.A.'s seafood processing facility in Costa Rica, identifying violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). An FDA 483, Inspectional Observations, was issued. The firm's November 11, 2014, response, including a revised HACCP plan and SOPs, was deemed inadequate.

The FDA determined that the firm's shrimp products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), as they were prepared, packed, or held under conditions that may render them injurious to health.

Significant deviations included: 1. Failure to list the food safety hazard of aquaculture drugs not approved for U.S. market shrimp in the revised HACCP plan for aquaculture farmed shrimp, violating 21 CFR 123.6(a) and (c)(1). 2. Inadequate critical limit for sulfite declaration at the Packing and Labeling critical control point in the updated HACCP plan for raw aquaculture farmed shrimp, violating 21 CFR 123.6(c)(3). The critical limit "All boxes must have the label, it must include all the bisulphite info and the word shrimp" was insufficient to ensure