FDA WARNING_LETTER - BJ Packers Inc. - June 09, 2008

An FDA inspection of BJ Packers Inc.'s seafood processing facility from May 28 to June 9, 2008, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and labeling requirements. The firm's cooked ready-to-eat crabmeat stew product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Additionally, several products were found to be misbranded under Section 403 of the Act.

Key HACCP violations included the failure to have and implement a written HACCP plan for their (b)(4) product to control pathogen growth and toxin formation, as required by 21 CFR 123.6(a) and (b). The firm also failed to maintain adequate sanitation control records, specifically lacking documentation for monitoring water safety, protection from adulteration, proper use of toxic compounds, employee health, and pest exclusion, violating 21 CFR 123.11(c).

Labeling deficiencies were extensive: the (b)(4) product failed to declare the major food allergen milk (Section 403(w)); allergen "Contains" statements were improperly placed (Section 403(w)(1)(A)); labels for (b)(4) and (b)(4) were false or misleading regarding "real cheese" claims when imitation cheese was used (Section 403(a)(1)); labels for (b)(4) and (b)(4) did not declare the correct manufacturer/packer/distributor name and place of business (Section 403(e)(1), 21 CFR 101.5); labels for (b)(4) and (b)(4) failed to declare sub-ingredients of enriched wheat flour (Section 403(i)(2), 21 CFR 101.4(b)(2)); "kasal sodium phosphates" was not declared by its common name "sodium aluminum phosphate" (21 CFR 101.4(a)); and labels for (b)(4) and (b)(4) failed to declare trans fat amounts (Section 403(q), 21 CFR 101.9(c)(2)(ii)).

BJ Packers Inc. must respond in writing within fifteen working days, outlining specific corrective actions and providing supporting documentation. Failure to correct these violations may result in further regulatory action, including product seizure and injunction. The firm is also reminded of bilingual labeling requirements for products distributed in Puerto Rico.