FDA WARNING_LETTER - Porfirios Italian Foods, Inc. - March 17, 2023

The FDA inspected a pasta manufacturing facility in Trenton, NJ, on January 13, 17, and March 17, 2023, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The pasta products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

The facility failed to prepare and implement a food safety plan overseen by a preventive controls qualified individual (PCQI), lacking a written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures.

Specific deficiencies include: - Failure to identify and evaluate allergens (wheat, milk, egg, lobster) as a hazard requiring preventive control, with inadequate sanitation practices (no detergent cleaning between allergen-containing products) leading to cross-contact risk. - Failure to identify and evaluate metal as a hazard, with broken metal screening in sifters and no metal detectors or visual inspection programs. - Failure to identify and evaluate mycotoxins (e.g., deoxynivalenol from wheat flour) as a hazard requiring preventive control, and no risk-based supply-chain program for raw materials.

The firm's March 29, 2023, response, proposing production scheduling, sanitation, allergen controls