FDA Inspection
Glenmark Pharmaceuticals Inc USAGlenmark Pharmaceuticals Inc USA – FDA Inspection, May 19, 2022
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Inc USA, with an inspection on May 19, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 19, 2022
- Product Type
- Drugs
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ID · c6d894dc-2cf7-4a92-a7a4-e3bc286496af
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1169876
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 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 |
| July 26, 2019 | VAI | Atlanta District Office | Generic Drug Evaluation |
| May 18, 2018 | VAI | Atlanta District Office | Generic Drug Evaluation |
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