FDA WARNING_LETTER - Onofrio's Fresh Cut, Inc. - July 29, 2021

The FDA inspected a produce processing facility at 222 Forbes Ave., New Haven, CT, from July 13-29, 2021, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR part 117). Environmental samples confirmed the presence of *Listeria monocytogenes* (L. mono), a human pathogen, in the facility. This led to the issuance of an FDA Form-483 and a determination that the RTE fresh-cut produce is adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Hazard Analysis and Risk-Based Preventive Controls (Subpart C):** Failure to appropriately evaluate environmental pathogens like L. mono as a hazard requiring a preventive control (21 CFR § 117.130(a)(1)). L. mono was found in four environmental swabs in 2021, and four in 2019, with different strains identified, indicating inadequate sanitation. The facility's produce wash does not effectively destroy pathogens, leading to a failure to establish supply-chain controls for pathogens at the receiving step (21 CFR § 117.135(a)(1)). 2. **Current Good Manufacturing Practice (Subpart B):** * Plant construction