FDA WARNING_LETTER - Arno Fritz GmbH - January 24, 2014

On June 9, 2014, the FDA issued a Warning Letter to Arno Fritz GmbH following an inspection from January 22-24, 2014, which found their Strasbourg Thoracic Osteosyntheses System (STRATOS) implant system to be adulterated and misbranded.

The inspection revealed significant violations of the Quality System regulation (21 CFR Part 820) and Medical Device Reporting (21 CFR Part 803). Key deficiencies included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(1))**: The firm's CAPA procedure lacked requirements for analyzing quality data using statistical methodology to identify nonconforming products or quality problems. The firm's response was inadequate as it did not specify data sources or statistical methods for analysis. 2. **Failure to control production processes (21 CFR 820.70(a))**: Procedures for specific STRATOS manufacturing processes were not established. The firm's response was insufficient, lacking details on a comprehensive review of all processes or a retrospective review of complaints/nonconforming products. 3. **Failure to maintain Device History Records (DHRs) (21 CFR 820.184)**: DHRs for multiple lots lacked documentation of critical manufacturing steps. The firm's response did not clarify how new