FDA WARNING_LETTER - Ventura Foods LLC - November 17, 2020

The FDA issued a Warning Letter to Mr. Furman on October 28, 2020, following a recall initiated on May 14, 2020, for misbranded Garlic Parmesan Sauce labeled as "Garlic Sauce." The product, manufactured at their Birmingham, AL facility, was found to be misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) because its label failed to declare major food allergens (milk and wheat) present in the Garlic Parmesan Sauce.

The firm also failed to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). Specifically, they did not identify and implement preventive controls for undeclared allergens at the labeling step, as required by 21 CFR 117.135(a)(1) and (c)(2). Additionally, their corrective action procedures were ineffective, failing to ensure all affected product was evaluated for safety and prevented from entering commerce, as required by 21 CFR 117.150(a)(2)(iii) and (iv), resulting in mislabeled product reaching customers.

The firm's July 15, 2020, email outlined corrective actions, including improved label management, updated procedures for label conversions and nonconforming product, required