FDA WARNING_LETTER - Combo AG - September 11, 2014

The FDA issued a Warning Letter to Combo AG Medizintechnik following inspections in September 2014, identifying significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803) for their Giger Medical Device with Biofeedback Mechanism.

The device was deemed adulterated under section 501(h) of the Act due to non-conformity with current good manufacturing practices. Key violations include: 1. **Design Control (21 CFR 820.30(a)):** Failure to establish and maintain design control procedures, with incomplete design documentation (no development plans, reviews, or change records). 2. **Complaint Handling (21 CFR 820.198(a)):** Absence of procedures for receiving, reviewing, and evaluating complaints, and lack of investigation documentation for a software-related complaint. 3. **CAPA (21 CFR 820.100(a)):** No documented procedures for corrective and preventive actions, and no CAPA documentation for a software change due to a complaint. 4. **Purchasing Controls (21 CFR 820.50):** Lack of procedures for purchasing controls or supplier qualification. 5. **Incoming Product Acceptance (21 CFR 820.80(b