FDA Inspection 787444 — Contec Medical Systems Co., Ltd.
The FDA completed an inspection of Contec Medical Systems Co., Ltd. on June 1, 2012 in Qinhuangdao. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Qinhuangdao (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 537 | 21 CFR 820.70(a) | Production processes |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |