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

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