1120599
Air Liquide Canada Inc. — FEI 3001774291
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 13, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hamilton (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |