FDA WARNING_LETTER - Dole Fresh Vegetables, Inc. - October 06, 2020

The FDA issued a Warning Letter to Mr. Solomon on September 25, 2020, following a product recall initiated on March 6, 2020. The recall was prompted by three consumer reports of an incorrect masterpack in HEB brand Tuscan Herb Chopped Salad Kit, which contained undeclared peanut butter, almond, cashew, and wheat. The firm attributed the mislabeling to an unintentional use of the wrong masterpack during production and a lack of a robust verification process for product changeover.

The primary violation cited is the failure to identify and implement preventive controls for undeclared allergens, as required by 21 CFR 117.135(a)(1) and (c)(2) of the CGMP & PC rule. This deficiency led to the adulteration and misbranding of the product. The firm indicated taking preventive actions, including modifying a "Masterpack consumption form" and implementing "Masterpack verification." The FDA will verify these corrective actions during a future inspection. The letter is not exhaustive of all violations. The firm must respond in writing within fifteen working days, detailing corrective actions, providing documentation, or explaining any delays. Failure to comply may result in regulatory actions like seizure or injunction.