# FDA WARNING_LETTER - Cotronic Technology Limited - July 16, 2015

Source: https://www.globalkeysolutions.net/records/warning_letter/cotronic-technology-limited/aa44e43d-32dc-4885-862c-eb61eeea68b6

> FDA WARNING_LETTER for Cotronic Technology Limited on July 16, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Cotronic Technology Limited
- Inspection Date: 2015-07-16
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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

## Related Officers

- [Office Director](https://www.globalkeysolutions.net/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.globalkeysolutions.net/companies/cotronic-technology-limited/fd100e2d-811f-4824-8965-8226b50445d1

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7