FDA Inspection
Galentic Pharma (India) Pvt. LtdGalentic Pharma (India) Pvt. Ltd – FDA Inspection, Feb 21, 2018
Record Details
This FDA Inspection record concerns Galentic Pharma (India) Pvt. Ltd, with an inspection on February 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0b96cda5-a773-432b-b689-50482ddb7002
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045052
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Galentic Pharma (India) Pvt. Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2026 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| December 8, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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