FDA WARNING_LETTER - Universal Pasteurization LLC - March 03, 2015

The FDA conducted an inspection of Universal Pasteurization, LLC's Coppell, Texas facility, which performs cold high-pressure processing (HPP) of juice products, on January 20, 22, February 5, and March 3, 2015. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering the firm's 100% juice blend products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm's April 14, 2015, response to the FDA 483 was deemed inadequate as it lacked specific corrective actions and timeframes. Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 120.7(a), 120.8(b)(1)):** The "Hazard Analysis - Juice" and "Pasteurized Juice Blends" HACCP plan failed to identify and address the hazard of pathogen growth and toxin formation, specifically *Clostridium botulinum*, in low-acid juice products like carrot juice, which the firm processes in hermetically sealed containers with unknown pH levels. 2. **Lack of Specific HACCP Plans (21 CFR 120.7(a), 21 CFR 12