FDA WARNING_LETTER - Bainbridge Beverage West, LLC - June 29, 2022

The FDA inspected a juice manufacturing facility in West Sacramento, CA, from June 9-29, 2022, identifying serious violations of the FDA’s juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), rendering juice products adulterated. The firm had not responded to the Form FDA-483.

Key violations include: 1. **HACCP Plan Validation:** Failure to validate the HACCP plan after a change in process, specifically after being notified of potentially hepatitis A-contaminated strawberries used in juice products. The HACCP plan did not identify hepatitis A as a hazard, and the High Pressure Processing (HPP) validation study did not cover it. 2. **Hazard Analysis Deficiencies:** The hazard analysis for "Cold Pressed Beverages" did not identify control measures for vegetative pathogens to achieve the required 5-log reduction. Additionally, Cryptosporidium parvum was not identified as a hazard or controlled for in apple juice products, despite using fresh apples and unpasteurized apple juice. 3. **Monitoring of CGMPs:** Failure to sufficiently monitor conditions and practices during processing to ensure conformance with Current Good Manufacturing Practices (CGMPs). This included inadequate monitoring of employee handwashing and unsanitary conditions such as an employee rinsing equipment in a handwashing station, an overfilled trash can with strawberries on the floor, an open ceiling tile above the filler line, heavy dust on