FDA WARNING_LETTER - Stratec Medizintechnik Gmbh - June 05, 2008

On June 2-5, 2008, an FDA inspection of Stratec Medizintechnik Gmbh in Pforzheim, Germany, revealed that their XCT 2000 and 3000 bone densitometers are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to adequately establish and maintain CAPA procedures (21 CFR 820.100(a)(1))**: The firm only analyzed German telephone service requests and failed to analyze other quality data sources (e.g., non-German service requests, faxes, emails). Statistical methodology for German data was inadequate, lacking stratification by device type or production year. The firm's undated response, received July 9, 2008, was deemed inadequate as it was in German, lacked a revised CAPA procedure, an English explanation of changes, and evidence of implementation or personnel training.

2. **Failure to adequately maintain complaint files and procedures (21 CFR 820.198(a))**: The firm failed to maintain complaint files for device malfunctions and obtain complaint information from its U.S. distributor. The response was inadequate, being in German, lacking a revised complaint handling procedure, an English explanation of changes, and