FDA Inspection
Atomvie Global Radiopharma Inc.Atomvie Global Radiopharma Inc. – FDA Inspection, Mar 27, 2018
Record Details
This FDA Inspection record concerns Atomvie Global Radiopharma Inc., with an inspection on March 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bb801417-85ba-418e-b4b6-b91100b52797
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1045820
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of Atomvie Global Radiopharma Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Atomvie Global Radiopharma Inc.
- FDA Inspection 1100903 - 2019-07-19
- FDA Inspection 843934 - 2013-07-26
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