FDA Inspection 906061 — Cathay Manufacturing Corp.
The FDA completed an inspection of Cathay Manufacturing Corp. on November 27, 2014 in Shanghai. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 27, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shanghai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |