Sometech Incorporated – FDA Warning Letter, Apr 26, 2012

On November 26, 2012, the FDA issued a Warning Letter to Sometech Incorporated following an inspection from April 23-26, 2012, in Seoul, South Korea. The inspection revealed 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 under section 501(h) of the Act.

The letter acknowledged partial responses from Sometech dated July 19 and October 23, 2012, but noted that additional violations discussed during the inspection were also included. Key violations cited include:

* **Failure to establish and maintain adequate procedures for corrective and preventative actions (CAPA)** (21 CFR 820.100(a)), with deficiencies in CAPA investigations and incomplete required actions like data analysis, statistical methodology, action identification, and verification/validation. * **Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints** (21 CFR 820.198(a)), as documented malfunctions were not processed as complaints, lacked MDR evaluation, and missed essential complaint details. * **Failure to establish and maintain procedures for design changes** (21 CFR 820.3