FDA WARNING_LETTER - RICARIMPEX SAS CO. - January 15, 2015

On January 12-15, 2015, an FDA inspection of Ricarimpex SAS in Eysines, France, identified that their medicinal leeches are adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's February 5, 2015, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Contamination Prevention (21 CFR 820.70(e)):** Failure to establish procedures for well water quality, which showed *Pseudomonas aeruginosa* and *E. coli* in 2013 and 2014. The firm's corrective action plan lacked a risk analysis for the impact on leeches. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100):** Failure to establish and maintain CAPA procedures. Specifically, CAPA "2014 1 P" regarding antibiotic use by a leech supplier did not initiate corrective actions for purchasing controls. CAPA "2014 1 I" was closed without verifying effectiveness. The revised CAPA procedure did not specify how recurring problems would be detected or risk levels determined. 3. **Purchasing Controls (