USA – FDA Warning Letter – Barsotti Juice Company, Inc.

FDA

We inspected your juice processing facility, located at 2239 Hidden Valley Lane, Camino, CA on November 20, November 21 and December 1, 2023. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR part 120), and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) in Title 21, Code of Regulations, Part 117 (21 CFR part 117). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your organic carrot juice is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. You may find the Act, the juice HACCP regulation and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at http://www.fda.gov.