881454
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 23, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4576 | 21 CFR 211.192 | No written record of investigation |