FDA WARNING_LETTER - Gexfix SA - January 16, 2013

On May 15, 2013, the FDA issued a Warning Letter to Gexfix SA following an inspection from January 14-16, 2013, in Carouge, Switzerland. The inspection found that Gexfix External Fixation Systems are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate device design (21 CFR 820.30(g))**: No testing supported the cleaning and sterilization instructions for use, and the firm lacked data to substantiate its suggested sterilization method. Identified risks, such as infection at pin insertion, were not evaluated for mitigation, and planned mitigations like sterilization validation were not performed. 2. **Failure to establish and maintain incoming product acceptance procedures (21 CFR 820.80(b))**: The firm did not implement its acceptance procedure for incoming products, failing to use the required ISO 2859-1 sampling plan for 10 of 11 incoming inspection reports. 3. **Failure to establish and maintain finished device acceptance procedures (21 CFR 820.80(d))**: Acceptance activities for assembly parts were not fully documented; 11