Gottfried Medical, Inc. – FDA Warning Letter, Mar 24, 2015

On March 9-24, 2015, an FDA inspection of Gottfried Medical, Inc., a manufacturer of medical support stockings, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) regulation (21 CFR Part 803). The devices were deemed adulterated and misbranded.

Key violations include: 1. **Corrective and Preventive Actions (CAPA)**: Inadequate procedures for initiating, verifying, validating, and recording CAPAs, and failure to analyze data sources using statistical methodology. 2. **Complaint Handling**: Procedures did not ensure all deficiencies were identified as complaints, were not updated for electronic documentation, and lacked documented MDR determinations. 3. **Nonconforming Product Control**: Failure to document, evaluate, and investigate in-process nonconformances and rework. 4. **Purchasing Controls**: Inadequate procedures for establishing and evaluating supplier requirements, controlling products/services from suppliers, and securing agreements for change notification. 5. **Design Changes**: Failure to establish and maintain procedures for formal review and approval of design changes. 6. **Device History Records (DHRs)**: No written DHR procedure. 7. **Quality Audits**: Audits conducted by individuals with direct responsibility for the audited matters. 8. **Management Review**: Failure to conduct management reviews at defined intervals.