FDA WARNING_LETTER - Freskeeto Frozen Foods Inc - March 11, 2013

The FDA conducted an inspection of Freskeeto Frozen Foods, Inc.'s food warehousing facility from March 5-11, 2013, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their vacuum-packed smoked salmon and herring in wine adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include the firm's failure to: 1. Have a HACCP plan for the receipt of vacuum-packed smoked salmon to control pathogen growth and toxin formation. 2. Have a HACCP plan for the receipt and storage of various marinated/pickled herring products to control scombrotoxin (histamine) and pathogen growth/toxin formation. These are repeat observations from an August 2012 inspection. 3. Ensure that personnel involved in HACCP have completed training or are qualified by job experience (21 CFR 123.10), also a repeat observation.

While the firm responded on March 12, 2013, and had previously promised corrections in September 2012, the FDA found the timeframe sufficient for correction and noted that monitoring is not in place at all necessary critical control points, such as product receiving. Intermittent temperature checks and checks only on workdays are deemed inadequate for refrigerated storage.