FDA Inspection
Gland Pharma Limited, Units I+II Pashamylaram SiteGland Pharma Limited, Units I+II Pashamylaram Site – FDA Inspection, Nov 7, 2019
Record Details
This FDA Inspection record concerns Gland Pharma Limited, Units I+II Pashamylaram Site, with an inspection on November 7, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 7, 2019
- Product Type
- Drugs
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ID · b1e79e8a-4766-4a82-8ce3-2f50924d5757
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109239
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| May 29, 2018 | Not classified | Office of Inspections and Investigations | |
| February 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1057719 - 2018-05-29
- FDA Inspection 1043371 - 2018-02-23
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