FDA Inspection
Gland Pharma LimitedGland Pharma Limited – FDA Inspection, Jul 25, 2024
Record Details
This FDA Inspection record concerns Gland Pharma Limited, with an inspection on July 25, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · acffcfce-62b6-4883-95ee-555ed8943c50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1244548
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Gland Pharma Limited
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 25, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 3, 2017 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| March 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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