FDA Inspection
Glenmark Pharmaceuticals Inc., USAGlenmark Pharmaceuticals Inc., USA – FDA Inspection, Jun 29, 2010
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Inc., USA, with an inspection on June 29, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 29, 2010
- Product Type
- Drugs
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ID · b98c41fe-947f-4d32-b8b3-d53ef954010a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669685
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Glenmark Pharmaceuticals Inc., USA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 9, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glenmark Pharmaceuticals Inc., USA
- FDA Inspection 996030 - 2016-12-05
- FDA Inspection 743660 - 2011-09-09
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