Onofrio's Fresh Cut, Inc.

Warning LetterClosed

Mr. Richard A. Onofrio Owner/President Onofrio's Fresh Cut, Inc. 222 Forbes Ave. New Haven , CT 06512 United StatesFEI 3004755864Issued Jan 10, 2022Office of Human and Animal Food Operations - East Division 1

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004755864.

Violations8

Issue DateJan 10, 2022

Product TypeFood & Beverages

StatusClosed

Closeout LetterJul 15, 2024

Letter Details

Firm: Onofrio's Fresh Cut, Inc.
Location: Mr. Richard A. Onofrio Owner/President Onofrio's Fresh Cut, Inc. 222 Forbes Ave. New Haven , CT 06512 United States
FEI Number: 3004755864
Country: United States
Issue Date: January 10, 2022
Issuing Office: Office of Human and Animal Food Operations - East Division 1
Product Type: Food & Beverages
Status: Closed
Closeout Letter: July 15, 2024

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.

Onofrio's Fresh Cut, Inc. FDA Warning Letter, January 10, 2022