FDA Inspection 1015063 — GLOBALCARE MEDICAL TECHNOLOGY CO., LTD
The FDA completed an inspection of GLOBALCARE MEDICAL TECHNOLOGY CO., LTD on Jun 8, 2017 in Zhongshan. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 8, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Zhongshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |