FDA Inspection 1045820 — Atomvie Global Radiopharma Inc.
The FDA completed an inspection of Atomvie Global Radiopharma Inc. on March 27, 2018 in Hamilton. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 27, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hamilton (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 17763 | 21 CFR 212.20(d) | Determination need for investigation |
| 17764 | 21 CFR 212.20(e) | Written QA procedures established, followed |
| 17853 | 21 CFR 212.60(d) | Supplies adequately controlled |