FDA Inspection 933112 — Hubei Weikang Protective Products Co., Ltd.
The FDA completed an inspection of Hubei Weikang Protective Products Co., Ltd. on June 4, 2015 in Xiantao. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 4, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Xiantao (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |