FDA WARNING_LETTER - Star Company S.A. - June 03, 2014

On June 2-3, 2014, the FDA inspected Star Company S.A.'s seafood processing facility in Guayaquil, Ecuador, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The FDA issued an FDA 483, Inspectional Observations.

The company's July 4, 2014, response addressed sanitation concerns but did not include a copy of their HACCP plan. The primary violation cited was the firm's failure to have a written HACCP plan for wild-caught and farm-raised shrimp to control food safety hazards, specifically aquaculture drugs in farm-raised shrimp and undeclared sulfites (food intolerance substances) in both types of shrimp, as required by 21 CFR 123.6(a) and (b). This renders their shrimp products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Star Company S.A. must respond in writing within 15 working days, outlining specific corrective steps. The response must include a copy of their HACCP plan and five consecutive days of completed monitoring records to demonstrate implementation. Failure to respond adequately may result in refusal of admission of imported products under Section 801(a) of the Act, including detention without physical examination (DWPE) via Import Alerts (e