USA – FDA Warning Letter – Bainbridge Beverage West, LLC- Microbial Risk

FDA

The U.S Food and Drug Administration (FDA) inspected your juice manufacturing facility, located at 2335 Del Monte Street, West Sacramento, CA 95691 on June 9, 10, 22, 24, and 29, 2022. We found that you have serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR 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 juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.External Link Disclaimer

To date, the agency has not received a written response from your firm regarding the violations noted on the Form FDA-483, Inspectional Observations, which was issued to your firm at the conclusion of the inspection.

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