799252
Apotex Inc. — FEI 3002906944
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 24, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North York (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1546 | 21 CFR 211.125(d) | Destruction of excess labels with lot numbers |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |