Panther James LLC – FDA Warning Letter, Aug 31, 2018

On February 12, 2019, the FDA issued a Warning Letter to a juice manufacturing facility at 2070 W. 11 Mile Rd., Berkley, MI, following an inspection from August 15-31, 2018. The inspection revealed serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering the juice products adulterated under 21 U.S.C. 342(a)(4).

The facility sells raw juice directly to consumers and distributes high-pressure processed juice to other businesses, thus not qualifying as a "retail establishment" exempt from HACCP regulations. The primary violation was the lack of adequate HACCP plans and insufficient 5-log treatment for pertinent microorganisms. The firm's September 24, 2018, response was deemed inadequate, specifically regarding the HACCP plans and the 5-log treatment. Furthermore, the process authority letter provided to support high-pressure processing parameters was found to rely on literature citations not directly applicable to the firm's process, with discrepancies in temperature, time, and product composition.

The FDA requires prompt corrective action, including validating the HPP process for each product. Failure to correct violations may result in legal action, including seizure and injunction, and the assessment of reinspection-related fees. The firm must respond in writing within fifteen working