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

Source: https://www.globalkeysolutions.net/records/warning_letter/ricarimpex-sas-co/6ead818d-f9e9-4388-8f68-22adefcdf7da

> FDA WARNING_LETTER for RICARIMPEX SAS CO. on January 15, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: RICARIMPEX SAS CO.
- Inspection Date: 2015-01-15
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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 (

## Related Officers

- [Jan B. Welch](https://www.globalkeysolutions.net/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)

Company: https://www.globalkeysolutions.net/companies/ricarimpex-sas-co/c065f850-4f69-4328-8518-af1b127e3108

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7