FDA Inspection 1116208 — Dong Guan Tanita Health Equipment Co., Ltd.
The FDA completed an inspection of Dong Guan Tanita Health Equipment Co., Ltd. on Jan 9, 2020 in Dong Guan. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 9, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dong Guan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |