Cotronic Technology Limited – FDA Warning Letter, Jul 16, 2015

On December 1, 2015, the FDA issued a Warning Letter to Cotronic Technology Limited following a July 13-16, 2015 inspection in Shenzhen, China. The inspection revealed that the firm's clinical electronic thermometers are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate the (b)(4) Clinical Electronic Thermometer, Model TM21. The firm's response was inadequate, lacking installation qualification (IQ) and performance qualification (PQ) documentation, and a retrospective analysis of other processes needing validation. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish and maintain CAPA procedures. The firm did not initiate CAPAs for exceeding quality objectives from 2013-2015. The response was inadequate, as it only addressed 2015 issues and did not confirm applicability to 2013 and 2014 data. 3. **Equipment Calibration (21 CFR 820.72(a)):** Failure to ensure routine calibration, inspection, checking