939621
Adamson Analytical Laboratories, Inc. — FEI 3000204955
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 14, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |