USA – FDA Warning Letter – Onofrio’s Fresh Cut, Inc. – Listeria monocytogenes

FDA

The United States Food and Drug Administration (FDA) inspected your produce processing facility located at 222 Forbes Ave., New Haven, CT 06512 from July 13, 2021 through July 29, 2021. During our inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, part 117 (21 CFR part 117). Additionally, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analysis of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. FDA’s inspection resulted in an issuance of a FDA Form-483 (FDA-483), Inspectional Observations, listing deviations found at your facility.

Based on FDA’s inspectional findings and the analytical results for the environmental samples, we have determined the RTE fresh-cut produce (e.g., onions, peppers, celery, broccoli, cantaloupe, watermelon, and kiwi) processed in your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that it was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 USC 331(uu)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.External Link Disclaimer

We received your responses sent via email on August 12, 2021, and August 17, 2021, which included a summary of corrective actions you have taken or plan to take. After reviewing the inspectional findings and your responses to the observations listed in the FDA-483, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.

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