# FDA WARNING_LETTER - Tailor Cut Produce Inc. - February 07, 2020

Source: https://www.keypedia.com/records/warning_letter/tailor-cut-produce-inc/c2e789d4-5436-40ac-a0a0-8c7c24ba02c2

> FDA WARNING_LETTER for Tailor Cut Produce Inc. on February 07, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Tailor Cut Produce Inc.
- Inspection Date: 2020-02-07
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA inspected Tailor Cut Produce in North Brunswick, NJ, from December 10, 2019, to February 7, 2020, following a multi-state *Salmonella Javiana* outbreak linked to their ready-to-eat (RTE) fresh-cut produce. The firm recalled products on December 6, 2019. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering their RTE produce adulterated.

Key violations include:
1.  **Inadequate Hazard Analysis:** Failure to identify and evaluate environmental pathogens as a hazard requiring preventive controls (e.g., sanitation controls) for RTE products exposed to the environment.
2.  **Insufficient Preventive Controls:**
    *   **Supply-Chain Controls:** No controls to ensure incoming whole fresh fruit has minimal pathogen contamination risk, and no written supply chain program with supplier approval/verification.
    *   **Sanitation Controls:** Failure to implement cleaning procedures (e.g., not cleaning equipment with detergent before sanitizing), lack of monitoring for sanitation practices, and non-implementation of handwashing SOPs (employees used hand sanitizer instead of washing hands, sinks were inaccessible).
3.  **Inadequate Environmental Monitoring:** No established written procedures for environmental monitoring for pathogens or indicator organisms, despite ATP testing being mentioned in policy.

## Related Documents

- [483 - 2020-02-07](https://www.keypedia.com/records/483/tailor-cut-produce-inc/57505ea9-20ea-45eb-9312-783522048d88)

## Related Officers

- [Senior Advisor ](https://www.keypedia.com/people/john-f-sheehan/32df49b4-cc47-4f74-a645-200f0563168c)

Company: https://www.keypedia.com/companies/tailor-cut-produce-inc/ac8afc63-b228-47c3-b3fd-30cf343d871b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e