FDA Inspection
Glenmark Pharmaceuticals Inc USAGlenmark Pharmaceuticals Inc USA – FDA Inspection, May 18, 2018
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Inc USA, with an inspection on May 18, 2018, issued by the Atlanta District Office, covering human drugs.
- Office
- Atlanta District Office
- People
- Jared P. Stevens (FDA Associated Person)
- Rachael L. Derby (Issuing Officer)
- Vincent Thomas (Issuing Officer)
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ID · 51543d47-6df2-4fe4-897e-2dd19b3aca7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052635
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| July 26, 2019 | VAI | Atlanta District Office | Generic Drug Evaluation |
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