FDA Inspection 1118442 — Odan Laboratories Ltd
The FDA completed an inspection of Odan Laboratories Ltd on February 20, 2020 in Pointe-Claire. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pointe-Claire (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |