FDA WARNING_LETTER - blessing inc. ( - September 05, 2008

On October 9, 2008, the FDA issued a Warning Letter to Blessing Inc. (DBA Blessing Seafood) following a September 5, 2008 inspection of their Tucson, AZ seafood importer establishment. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123, specifically concerning imported fish and fishery products under 21 CFR 123.12.

The FDA found that Blessing Inc. did not have or had not implemented written verification procedures to ensure imported fish comply with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2). Specifically, the firm lacked written product specifications and affirmative steps for Scombrotoxin-producing fish (mackerel and yellowtail). Furthermore, the company failed to maintain records documenting the performance and results of affirmative steps, a violation of 21 CFR 123.12(c) and 123.9.

These violations render the Scombrotoxin-forming fish 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 potentially injurious to health. The FDA warned that failure to promptly correct these violations