FDA Inspection
Glenmark Pharmaceuticals Inc USAGlenmark Pharmaceuticals Inc USA – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Inc USA, with an inspection on July 26, 2019, issued by the Atlanta District Office, covering human drugs.
- Office
- Atlanta District Office
- Person
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ID · 1590af97-9645-4c46-b18b-24ab434e394f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097806
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Glenmark Pharmaceuticals Inc USA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2025 | Not classified | Atlanta District Office | Drug Quality Assurance |
| May 19, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2018 | VAI | Atlanta District Office | Generic Drug Evaluation |
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