FDA WARNING_LETTER - Frozen Food Development Inc - November 30, 2023

The FDA inspected an individually quick frozen (IQF) ready-to-eat (RTE) fruits and vegetables facility in Elizabethtown, PA, from October to November 2023, identifying serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Consequently, the facility's products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, with non-compliance also prohibited by Section 301(uu). Key deficiencies include the failure to implement effective measures to exclude pests and prevent food contamination, as evidenced by significant rodent activity (21 CFR Part 117.35(c)), a recurring issue. The firm also failed to establish and implement a risk-based supply-chain program for raw materials with identified hazards, specifically pathogens in frozen RTE produce, lacking appropriate supplier verification activities like annual onsite audits (21 CFR 117.405(a)(1)). Furthermore, the facility did not identify and evaluate Cyclospora as a known hazard requiring preventive control in frozen RTE berry products (21 CFR Part 117.130(a)(1)), another repeat violation. The firm's submitted corrective action plan was deemed inadequate. The FDA requires a written response within 15 working days detailing specific corrective actions, recurrence prevention, and supporting documentation, warning that failure to comply could lead to legal action, including seizure and injunction.