Teamedics (Taishan) Manufacturing Co., Ltd – FDA Warning Letter, Sep 6, 2007

On September 3-6, 2007, an FDA inspection of Teamedics (Taishan) Manufacturing Co., Ltd. in Shenzhen, China, revealed that their heating pads, classified as medical devices, were adulterated. The firm's manufacturing, packing, storage, or installation methods and controls did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Process Validation (21 CFR 820.75):** Failure to validate semi-automated PVC welders and establish monitoring procedures for these processes. 2. **CAPA Procedures (21 CFR 820.100):** Absence of established written corrective and preventive action procedures. 3. **Design History File (21 CFR 820.30(j)):** Failure to maintain design history files for each device type, with documents being discarded after two years. 4. **Production and Process Controls (21 CFR 820.70(a)):** Lack of written work instructions for soldering and unvalidated testing equipment for heating levels. 5. **Acceptance Activities (21 CFR 820.80(a)):** No written procedures for using testing equipment, and release of products that did not meet specifications. 6. **Environmental Control (