FDA WARNING_LETTER - Compumedics Germany Gmbh - March 22, 2012

On August 1, 2012, the FDA issued a Warning Letter to Compumedics Germany Gmbh following an inspection from March 19-22, 2012. The inspection revealed that the firm's Class II pulsed Doppler ultrasonic imaging diagnostic systems were adulterated under 21 U.S.C. § 351(h) due to non-conformity with current good manufacturing practice requirements of the Quality System regulation (21 CFR Part 820).

Key violations included: 1. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate processes and monitor parameters for validated processes. The firm's April 4, 2012, response was deemed inadequate as it lacked sufficient detail and documentation for revised validation and monitoring procedures. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish and maintain adequate CAPA procedures, specifically lacking requirements for statistical methodology, investigation of nonconformities, verification/validation of effectiveness, and documentation of changes. The response was inadequate as the revised CAPA procedure was not provided, and it was unclear if all requirements would be addressed. 3. **Design Validation (21 CFR 820.30(g)):** Failure to adequately validate device design, including proper documentation in the