FDA Inspection
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Limited, with an inspection on August 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 84e00ca0-c1d9-49f1-aa35-11332d0d7eec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065438
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Glenmark Pharmaceuticals Limited
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 28, 2025 | Not classified | Office of Inspections and Investigations | |
| September 20, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 21, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for Glenmark Pharmaceuticals Limited
- FDA Inspection 1298220 - 2025-11-28
- FDA Inspection 1252922 - 2024-09-20
- FDA Inspection 1226884 - 2023-12-15
- FDA Inspection 1122444 - 2020-02-21
- FDA Inspection 1025068 - 2017-07-21
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