637086
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 30, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |