FDA WARNING_LETTER - Rigid FX Orthopedics, Inc - August 29, 2012

On August 27-29, 2012, an FDA inspection of Rigid FX Orthopedics, Inc. in Austin, Texas, a specification developer of the Clearview Wrist Fixation System, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803). The devices were deemed adulterated and misbranded.

Key violations include: 1. **Design Control (21 CFR 820.30(a)):** Failure to establish adequate design control procedures, including design plan, inputs, outputs, reviews, verification, validation, and changes for the Clearview Wrist Fixation System. 2. **Process Validation (21 CFR 820.75(a)):** Failure to validate re-sterilization processes (repeat (b)(4) and (b)(4) cycles) used to extend device sterility expiration dates, leading to discoloration and unknown effects on functionality and material. 3. **Corrective and Preventive Action (21 CFR 820.100(a)):** Absence of written procedures for CAPA. 4. **Complaint Handling (21 CFR 820.198(a)):** Absence of written procedures for receiving, reviewing, and evaluating complaints. 5. **Purchasing Controls (21 CFR