FDA WARNING_LETTER - Flying Food Group, Inc. - August 01, 2011

The FDA issued a Warning Letter to Flying Food Group, Inc. following an inspection of their Newark, NJ airline catering facility from July 18 to August 1, 2011. Significant violations of Interstate Conveyance Sanitation regulations (21 CFR Part 1250) and Seafood HACCP regulations (21 CFR Part 123) were found, resulting in a classification change from “Approved” to “Provisional.” Interstate Conveyance violations included failure to maintain perishable food at or below 50°F (21 CFR 1250.27), food handling operations not minimizing contamination (21 CFR 1250.32(a)) due to condensation, inadequate plumbing maintenance (21 CFR 1250.30(d)), and utensils not maintained in good repair (21 CFR 1250.33(a)). Seafood HACCP violations involved failing to conduct a proper hazard analysis for tuna products, specifically omitting histamine formation (21 CFR 123.6(a) and (c)(1)), and having an inappropriate corrective action plan for tuna products that could allow pathogen growth (21 CFR 127.3(b)). Consequently, their seafood products are considered adulterated under Section 402(a)(4) of the FD&C Act. The firm's initial response to the FDA 483 was inadequate. Flying Food Group must promptly correct all violations and notify FDA within fifteen working days with specific steps, recurrence prevention plans, and supporting documentation. Failure to comply could lead to a "Use Prohibited" classification, impacting their airline catering operations. Recommendations were also made regarding recordkeeping and thermometer accessibility.