Sometech Incorporated – FDA Warning Letter, Nov 4, 2010

On April 6, 2011, the FDA issued a Warning Letter to Sometech Incorporated following an inspection from November 1-4, 2010, in Seoul, South Korea. The inspection found that Sometech, a manufacturer of medical imaging equipment and high-frequency surgical instruments, was not in conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated.

Key violations included: 1. **Corrective and Preventive Actions (CAPA) (21 CFR 820.100(a)):** Failure to establish adequate CAPA procedures, including analysis of quality data, identifying recurrence prevention actions, verification/validation of actions, implementing/recording changes, and disseminating information. Five CAPAs for US devices in 2009-2010 were deficient. 2. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints, including uniform and timely processing, MDR evaluation, investigation necessity determination, and complete recordkeeping. All 2009-2010 US device complaints were deficient. 3. **Design Control (21 CFR 820.30(c, d, e, f, g, i, j)):**