# FDA WARNING_LETTER - Dexcowin Co. Ltd. - August 31, 2017

Source: https://www.keypedia.com/records/warning_letter/dexcowin-co-ltd/b389e6b4-c557-4e65-8e6d-30a9a890bc41

> FDA WARNING_LETTER for Dexcowin Co. Ltd. on August 31, 2017. Product: Devices. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Dexcowin Co. Ltd.
- Inspection Date: 2017-08-31
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On February 20, 2018, the FDA issued a Warning Letter to Dexcowin Co., Ltd. following an inspection from August 28-31, 2017, which found their portable dental diagnostic X-ray devices to be adulterated. The firm's manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820).

Key violations include:
1.  **CAPA (21 CFR 820.100(a)):** Failure to verify/validate CAPA effectiveness, not processing a battery supplier change through CAPA, and not reporting all CAPAs in management reviews.
2.  **Design Validation (21 CFR 820.30(g)):** Lack of predefined methods, operating conditions, and acceptance criteria for design validation, specifically for X-ray tube conformance, X-ray exposures per battery charge (worst-case not accounted for), remote control functionality, and X-ray field diameter.
3.  **Design Change (21 CFR 820.30(i)):** Inadequate documentation, validation, and approval of design changes, including insufficient justification for test parameters and missing test results/equipment details.
4.  **Inspection, Measuring, and Test Equipment (21 CFR 820.72(a)):** No documentation of qualification

## Related Documents

- [483 - 2017-08-31](https://www.keypedia.com/records/483/dexcowin-co-ltd/bd3b638c-c86a-4044-9950-84fe20fc3164)

## Related Officers

- [Claude Berthoin](https://www.keypedia.com/people/claude-berthoin/b3fcf1dd-8c02-4a21-bdfb-93b9c13bd677)
- [Donald St. Pierre](https://www.keypedia.com/people/donald-st-pierre/d2e2e0ca-b277-4fbb-9e1a-5c06308531ed)

Company: https://www.keypedia.com/companies/dexcowin-co-ltd/95b6ec0f-e5d8-4d7d-8eb8-d5d31e4633c5

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