FDA WARNING_LETTER - Winter Gardens Quality Foods, Inc. - August 18, 2020

On August 5, 2020, the FDA issued a Warning Letter to a New Oxford, PA firm regarding their recalled Whole Foods brand Vodka Sauce. The FDA determined the product was misbranded under section 403(w) of the Act because the finished product label failed to declare milk, a major food allergen.

The firm also violated the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Specifically, they failed to identify and implement preventive controls for undeclared allergens at the labeling step, as required by 21 CFR 117.135(a)(1) and (c)(2). This was evidenced by the mislabeling of Vodka Sauce with Puttanesca Sauce back panel ingredient labels, which do not declare milk.

The firm recalled the product on March 20, 2020, after customer notification. They attributed the error to an associate not properly checking the new roll of labels. On June 10, 2020, the firm provided an updated "Procedure for Proper Packaging and Labeling" and employee training records as corrective actions. The FDA will verify implementation during the next inspection.

The letter emphasizes the firm's responsibility to comply with the Act and CGMP & PC rule. Failure to correct violations may result in regulatory action, including seizure and injunction. The firm must respond in writing within