FDA Inspection
Genvion CorporationGenvion Corporation – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns Genvion Corporation, with an inspection on July 28, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 23b52120-0b49-4f0b-93eb-308a5358d95d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216476
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Genvion Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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