FDA Inspection
Gland Pharma Limited, Units I+II Pashamylaram SiteGland Pharma Limited, Units I+II Pashamylaram Site – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns Gland Pharma Limited, Units I+II Pashamylaram Site, with an inspection on February 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 23, 2018
- Product Type
- Drugs
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ID · 2a89c877-04b5-44c9-bda9-2d69a6bcbb57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1043371
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.110(b)In-process conformity - examination, sample testing
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Other FDA inspections of Gland Pharma Limited, Units I+II Pashamylaram Site
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
| August 26, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Gland Pharma Limited, Units I+II Pashamylaram Site
- FDA Inspection 1244660 - 2024-08-02
- FDA Inspection 1216053 - 2023-08-26
- FDA Inspection 1210478 - 2023-06-27
- FDA Inspection 1109239 - 2019-11-07
- FDA Inspection 1057719 - 2018-05-29
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