As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Tailor Cut Produce Inc.
North Brunswick, NJ
Tailor Cut Produce Inc. has been under scrutiny since Dec. 6, when the FDA began investigating a Salmonella Javiana outbreak connected to Tailor Cut Produce. The company issued a recall Dec. 7 of its fruit luau, cut honeydew, cut cantaloupe and cut pineapple products. This warning letter shows the conditions at Tailor Cut Produce Inc.’s processing facility that could have led to the outbreak that sickened more than 150 people in 14 states.
In a July 8 warning letter the FDA described a Dec.10, 2019, through Feb. 7, 2020, inspection at Tailor Cut Produce Inc.’s ready-to-eat (RTE) fresh-cut produce processing facility. The inspection was initiated as part of an ongoing Salmonella Javiana multi-state outbreak investigation. FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
FDA’s inspection resulted in the issuance of FDA Form 483.