FDA Inspection 867569 — Foshan Flying Medical Products Co., Ltd.
The FDA completed an inspection of Foshan Flying Medical Products Co., Ltd. on January 10, 2014 in Foshan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 10, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Foshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3696 | 21 CFR 820.100(b) | Documentation |