Onofrio's Fresh Cut, Inc. Warning Letter Details

Summary

Onofrio's Fresh Cut, Inc. was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls regulations while processing ready-to-eat fresh-cut produce including onions, peppers, celery, broccoli, cantaloupe, watermelon, and kiwi. FDA environmental testing of the facility detected Listeria monocytogenes, a human pathogen, in multiple areas, indicating the produce was prepared, packed, or held under insanitary conditions and therefore adulterated. The inspection, conducted from July 13-29, 2021, identified deviations documented on an FDA Form-483, and the company's corrective action responses submitted in August 2021 were reviewed against the findings.