FDA Inspection 825428 — He Gao Plastic Factory
The FDA completed an inspection of He Gao Plastic Factory on March 14, 2013 in Shantou. 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
- March 14, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shantou (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |