FDA Inspection
Glenmark Pharmaceuticals LimitedGlenmark Pharmaceuticals Limited – FDA Inspection, Apr 20, 2019
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Limited, with an inspection on April 20, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- Justin A. Boyd (Investigator)
- Rita K. Vick (Issuing Officer)
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ID · 3d480abd-bd12-4e91-b835-c48415d17346
Inspection Facts
- Inspection number
- 1087639
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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Other FDA inspections of Glenmark Pharmaceuticals Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 11, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2017 | Not classified | Office of Inspections and Investigations | |
| May 29, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glenmark Pharmaceuticals Limited
- FDA Inspection 1172425 - 2022-06-22
- FDA Inspection 1070594 - 2018-09-21
- FDA Inspection 1031652 - 2017-11-11
- FDA Inspection 1012923 - 2017-04-19
- FDA Inspection 929619 - 2015-05-29
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