FDA Inspection
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited – FDA Inspection, Sep 27, 2019
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Limited, with an inspection on September 27, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 2ecc5ee7-1d47-4269-84ae-e280ac4fbe41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103081
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Glenmark Pharmaceuticals Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2017 | Not classified | Office of Inspections and Investigations | |
| May 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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