FDA Inspection
Amerigen Pharmaceuticals Inc.Amerigen Pharmaceuticals Inc. – FDA Inspection, Jul 27, 2017
Record Details
This FDA Inspection record concerns Amerigen Pharmaceuticals Inc., with an inspection on July 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 871e5fa7-22b9-4005-9c90-2e8adfd939e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019314
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amerigen Pharmaceuticals Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Amerigen Pharmaceuticals Inc.
- FDA Inspection 1077150 - 2019-01-18
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