FDA Inspection
Glenmark Pharmaceuticals Inc USAGlenmark Pharmaceuticals Inc USA – FDA Inspection, Jun 17, 2025
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Inc USA, with an inspection on June 17, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · 3ab7d010-f073-47f9-8788-ab4b11e320be
Inspection Facts
- Inspection number
- 1267093
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of Glenmark Pharmaceuticals Inc USA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2019 | VAI | Atlanta District Office | Generic Drug Evaluation |
| May 18, 2018 | VAI | Atlanta District Office | Generic Drug Evaluation |
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