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

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.