Raw Juicery, Inc. – FDA Warning Letter, Nov 12, 2019

On November 6 and 12, 2019, the FDA inspected a facility at 915 Mateo St., Ste 207, Los Angeles, CA, manufacturing 100% and <100% juice products. The inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 120.

The primary violation identified was that the company's HACCP plan for Juice Blends failed to list patulin as a food safety hazard, despite the hazard analysis identifying it as reasonably likely to occur. This renders the manufactured juice products adulterated under section 402(a)(4) of the Act [21 U.S.C. §342(a)(4)], as they were prepared, packed, or held under insanitary conditions potentially injurious to health.

The FDA requires the company to ensure its HACCP plan complies with 21 CFR 120.8(b)(1) by listing all reasonably likely food safety hazards, including patulin. The company is also responsible for complying with 21 CFR Part 117 (Current Good Manufacturing Practice regulation).

The company must respond in writing within fifteen working days of receiving the letter, detailing specific corrective actions taken, steps to prevent recurrence, and supporting documentation. If corrections cannot be completed