FDA WARNING_LETTER - Tova Industries, LLC - August 08, 2024

An FDA inspection conducted from August 5-8, 2024, at your dry goods and ready-to-eat (RTE) foods facility in Jeffersontown, KY, revealed serious violations of the Emergency Permit Control regulation (21 CFR Part 108) and Acidified Foods regulation (21 CFR Part 114). As an acidified food processor, your firm is required to comply with these regulations. Significant violations included the failure to establish a scheduled process by a qualified person for numerous products, such as various pancake syrups, vanilla extracts/flavorings, and soy sauces, as required by 21 CFR 114.83. Additionally, your firm failed to provide the FDA with information regarding the scheduled process, including heat processing conditions, pH control, and other critical parameters for each acidified food and container size, as mandated by 21 CFR 108.25(c)(2). The firm's response to the FDA-483 was deemed inadequate, with filings marked as "Incomplete." Failure to promptly correct these violations may lead to further FDA action, including product seizure and/or injunction against your firm's operations. A written response outlining specific corrective actions, including product formulations and process filing information, is required within fifteen working days. The firm is also responsible for complying with other applicable regulations, such as 21 CFR Part 117.