1035031
Odan Laboratories Ltd — FEI 3002706162
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 15, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pointe-Claire (Canada)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |