FDA Inspection 757377 — Shanghai Shunlong Physical Therapy Equipment Co. Ltd.
The FDA completed an inspection of Shanghai Shunlong Physical Therapy Equipment Co. Ltd. on October 20, 2011 in Shanghai. 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
- October 20, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shanghai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |