FDA Inspection
Glenmark Pharmaceuticals LtdGlenmark Pharmaceuticals Ltd – FDA Inspection, Feb 26, 2016
Record Details
This FDA Inspection record concerns Glenmark Pharmaceuticals Ltd, with an inspection on February 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Glenmark Pharmaceuticals Ltd
- Inspection Date
- February 26, 2016
- Product Type
- Drugs
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ID · ba4a8656-dfe3-4b6e-bdf3-dc6d2c4a55c2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 962557
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.142Written warehousing procedures established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Glenmark Pharmaceuticals Ltd
8| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2025 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| February 25, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 26, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Glenmark Pharmaceuticals Ltd
- FDA Inspection 1260403 - 2025-02-14
- FDA Inspection 1122868 - 2020-02-25
- FDA Inspection 1107098 - 2019-09-13
- FDA Inspection 1053034 - 2018-05-24
- FDA Inspection 1028538 - 2017-08-26
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