FDA Inspection
Gland Pharma Limited, Units I+II Pashamylaram SiteGland Pharma Limited, Units I+II Pashamylaram Site – FDA Inspection, Aug 26, 2023
Record Details
This FDA Inspection record concerns Gland Pharma Limited, Units I+II Pashamylaram Site, with an inspection on August 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 26, 2023
- Product Type
- Devices
View Company Profile
ID · 955ba795-ebdd-4ebb-861f-16909163e529
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1216053
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.186QSR
- 21 CFR 820.186QSR
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
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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 |
| 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 | |
| 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 1210478 - 2023-06-27
- FDA Inspection 1109239 - 2019-11-07
- FDA Inspection 1057719 - 2018-05-29
- FDA Inspection 1043371 - 2018-02-23
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