656888
Constant Irwindale, Inc. — FEI 1000125593
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Irwindale, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |