653183
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maricao, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |