FDA WARNING_LETTER - Storz Medical, AG - March 19, 2010

On March 15-19, 2010, an FDA inspection of Storz Medical, AG in Tagerwilen, Switzerland, identified that their Modulith SLK and Modulith SLX-F2 devices are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

The firm's March 29, 2010, response to the FDA 483 was deemed inadequate. Violations include: 1. **Failure to validate corrective and preventive actions (21 CFR 820.100(a)(4))**: No protocol or documentation for validating Change Request (b)(4) to fix cracked cooling pumps in Modulith SLX-F2. The response lacked evidence of correction or systemic action. 2. **Failure to control nonconforming product (21 CFR 820.90(a))**: No documentation of evaluation and disposition for defective pumps (serial numbers (b)(4), (b)(4), (b)(4)). The response lacked evidence of correction or systemic action. 3. **Failure to investigate complaints (21 CFR 820.198(c))**: Complaint# (b)(4)