FDA WARNING_LETTER - OLMA-XXI Inc - October 23, 2007

On January 16, 2008, the FDA issued a Warning Letter to OLMA-XXI Inc. following inspections on September 19, 21, and October 22, 23, 2007. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The FDA determined that the firm's refrigerated, ready-to-eat, vacuum-packed smoked fishery products (smoked salmon, paltus, mackerel), refrigerated, ready-to-eat, vacuum-packed shmaltz/brined herring, and refrigerated, unpasteurized, ready-to-eat reduced oxygen packed salmon caviar/roe were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plan:** The firm lacked a HACCP plan for refrigerated, ready-to-eat, vacuum-packed smoked fishery products and shmaltz/brined herring to control pathogen growth, toxin formation (including *Clostridium botulinum*), and scombrotoxin formation (for herring and mackerel). (21 CFR 123.6(a) and (