FDA WARNING_LETTER - National Food & Beverage, Inc - June 20, 2012

On October 26, 2012, the FDA issued a Warning Letter to National Food & Beverage, Inc. following an inspection from June 14-20, 2012, at their Dallas, Texas facility, where they manufacture acidified foods. The inspection revealed serious violations of 21 CFR Part 108 (Emergency Permit Control) and Part 114 (Acidified Foods), rendering their products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, the firm failed to file scheduled processes for several acidified foods, including Wasabi Aioli Sauce and Buffalo Aioli Sauce, as required by 21 CFR 108.25(c)(2). Despite a June 27, 2012, response indicating these would be filed, the FDA had not received them as of the Warning Letter date. Additionally, the company failed to maintain processing and production records showing adherence to scheduled processes, including critical measurements of fill temperature, hold temperature, and/or hold time for multiple lots of acidified foods produced between February 29, 2012, and June 15, 2012, violating 21 CFR 114.100(b). While the firm stated intentions to establish guidelines and purchase a data-logger, no evidence of implementation or personnel training was provided.

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