FDA WARNING_LETTER - Panther James LLC - November 02, 2020

The FDA inspected Drought's juice manufacturing facility in Berkley, MI, from October 15 to November 2, 2020, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). The facility produces raw untreated juice sold onsite and at retail establishments, and processed juice sold to other businesses and retail.

The FDA determined the Berkley facility is not a "retail establishment" under 21 CFR 120.3(l) because it sells juice to other business entities, making all juice produced there subject to HACCP regulations. Violations include the absence of a written HACCP plan for numerous unprocessed juices (e.g., Apple Lemon Ginger, Green #1, Watermelon) and failure to apply a 5-log reduction of pertinent microorganisms to these juices prior to distribution, as required by 21 CFR 120.8(a) and 21 CFR 120.24(a). This renders the raw untreated juice adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA reviewed the firm's responses from April 6, May 19, and November 24, 2020, finding them inadequate. The FDA noted shared operations between the firm and a separate entity at the Berkley facility, indicating the facility is