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

A comprehensive FDA inspection of Tailor Cut Produce Inc., a fresh-cut fruit and vegetable manufacturer located in North Brunswick, NJ, was conducted from December 10, 2019, to February 7, 2020. This for-cause inspection, initiated in response to a Salmonella Javiana outbreak linked to the company's products, focused on compliance with Preventive Controls and Sanitary Human Food Operations regulations (CPGM 7303.040, 21 CFR 117). Major violations documented on an FDA Form 483 included the firm's failure to identify recontamination with environmental pathogens as a hazard requiring a preventive control in its hazard analysis for ready-to-eat fruit products. The company also lacked an adequately validated preventive control for biological hazards on incoming whole fruits, as its washing solution lacked scientific support for effectiveness against pathogens like Salmonella. Significant sanitation deficiencies were observed, such as non-adherence to written cleaning and hand washing policies—including inaccessible handwashing sinks—and the absence of environmental monitoring. Furthermore, facility floors in processing areas and coolers exhibited cracks and pooled water, and some equipment was not constructed of easily cleanable materials. Other concerns noted were inadequate finished product storage temperatures, undocumented employee food safety training, a food safety plan not overseen by a Preventive Controls Qualified Individual, and a failure to document customer complaints. Prior to the inspection, Tailor Cut Produce Inc. initiated a voluntary recall of various fruit products. Management committed to providing a written response to the FDA 483 within 15 business days, outlining corrective actions, and was informed of potential regulatory and legal consequences for observed violations.