FDA WARNING_LETTER - Bellisio Foods Inc - November 29, 2012

On November 27-29, 2012, the FDA inspected a seafood processing facility at 100 E. Broadway St., Jackson, OH, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's frozen entrees containing shrimp were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

The firm's December 17, 2012, response was inadequate as deviations remained uncorrected, and further review identified additional issues. Significant violations include: 1. Failure to list allergens (shrimp, milk, wheat) as food safety hazards in the HACCP plan for frozen entrees containing shrimp, violating 21 CFR 123.6(a) and (c)(1). Prerequisite programs are insufficient for reasonably likely hazards. 2. Failure to list critical control points (sauce holding tank, rework/carryover sauce, pasta blanching, pasta filling) in the HACCP plan for pathogen growth and toxin formation, violating 21 CFR 123.6(a) and (c)(2). 3. Inadequate critical limits in the HACCP plan, violating 21 CFR 123.6(c)(3). The cooking and cooling