FDA WARNING_LETTER - Galil Importing Corp. - April 01, 2014

On March 27-April 1, 2014, the FDA inspected Galil Importing Corp. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically 21 CFR 123.12 for imported fish and fishery products. The firm failed to implement an affirmative step to ensure imported ready-to-eat (RTE) canned sardines in vegetable oil and RTE canned sardines in olive oil from (b)(4) were processed in accordance with seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

This deficiency renders the RTE canned tuna in vegetable oil from (b)(4), and the RTE canned sardines in vegetable oil and RTE canned sardines in olive oil from (b)(4) adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA warned that failure to promptly correct these violations could lead to refusal of admission for imported products under Section 801(a) of the Act, including "detention without physical examination," product seizure, and/or injunction. The firm was required to respond in writing within fifteen working days, outlining specific corrective actions