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Bainbridge Beverage West, LLC manufactured juice products under insanitary conditions without a compliant Hazard Analysis and Critical Control Point (HACCP) plan, violating 21 CFR Part 120. During a June 2022 inspection, the FDA found that the company failed to validate its HACCP plan after receiving notification on June 1, 2022, that organic strawberries used in their juice products were potentially contaminated with hepatitis A, yet continued production without adequately reassessing food safety hazards. The company had not responded to the inspectional observations documented on the FDA Form 483 at the time the warning letter was issued.