Barsotti Juice Company, Inc. – FDA Warning Letter, Dec 1, 2023

On January 30, 2024, the FDA issued a Warning Letter to a juice processing facility in Camino, CA, following an inspection from November 20 to December 1, 2023. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Specifically, the facility's organic carrot juice was deemed adulterated because it was prepared, packed, or held under insanitary conditions, potentially rendering it injurious to health. The primary violations included:

1. **Inadequate 5-log reduction:** The HACCP plan failed to ensure a consistent 5-log reduction in the most resistant microorganism (Clostridium botulinum) for the product's shelf life. The pasteurization critical limit of (b)(4) was insufficient to inactivate C. botulinum spores, and the provided challenge study and justification were deemed inadequate. 2. **Missing Critical Control Points (CCPs):** The HACCP plan did not identify CCPs for maintaining product refrigeration and finished product refrigerated storage to control C. botulinum growth and toxin formation. While a revised plan identified some steps as CCPs for "biological" hazards, it did not specifically define C. botulinum, and