FDA WARNING_LETTER - Texas Plum Line - June 22, 2017

From June 19-22, 2017, the FDA inspected Texas Plum Line, a manufacturer of low-acid and low water activity food products. The inspection revealed serious violations of 21 CFR 108 (Emergency Permit Control), 21 CFR 113 (Low-Acid Canned Foods - LACF), and 21 CFR 110 (Current Good Manufacturing Practice - CGMP). These violations render the firm's LACF and low water activity products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to Register and File Scheduled Processes:** The firm failed to register with the FDA as a commercial processor of low-acid foods and did not file a scheduled process for its "Special Dark Chocolate Cake with Maraschino Cherries," which was confirmed by laboratory testing to be a low-acid food (pH 6.21-6.53, water activity 0.880-0.887). These are repeat observations from an October 24, 2011, Untitled Letter. 2. **Lack of Qualified Person for Scheduled Process:** The firm failed to have a scheduled process established by a qualified person for its "Special Dark Chocolate Cake with Maraschino Cherries." 3. **Inadequate Product Coding:** Hermetically sealed containers