FDA WARNING_LETTER - Russ Davis Wholesale Inc - January 19, 2022

The FDA inspected Russ Davis Wholesale Inc.'s RTE food and beverage facility in Eagan, Minnesota, from December 2021 to January 2022. The inspection revealed serious violations of the Juice HACCP regulation (21 CFR Part 120) and the CGMP & PC rule (21 CFR Part 117), rendering their citrus juice and RTE snack products adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Juice HACCP (21 CFR 120.10(b)):** Failure to take corrective actions when critical limits for citrus fruit treatment were not met on multiple dates in November 2021. The firm's proposed corrective action was inadequate, and their new monitoring method requires validation and HACCP plan updates. 2. **Juice HACCP (21 CFR 120.11(b)):** Failure to validate the HACCP plan after a process change. The firm's reliance on an external laboratory validation for their 5-log reduction treatment was insufficient, as it was not adequately verified under their facility's conditions. Processing records also lacked product identity and lot/batch numbers (21 CFR 120.12(b)(4)). 3. **Current Good Manufacturing Practice (21 CFR 117.80(a