Company
IndiaGland Pharma Limited, Hyderabad, India – FDA Inspections
Inspection records and compliance data for Gland Pharma Limited in Hyderabad. 8 FDA inspections on record, 3 Form 483s, last inspected July 25, 2024.
Company Profile
This profile covers Gland Pharma Limited based in Hyderabad, India.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 7
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected January 7, 2011. Last inspected July 25, 2024.
Most cited issue areas
- Complete test data included in records2 inspections
- Environmental Monitoring System2 inspections
- Backup file not maintained1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 25, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1244548 |
| July 14, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1210381 |
| August 25, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1179407 |
| May 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1090548 |
| February 3, 2017 | VAI | Human Drugs · Generic Drug Evaluation | 1002974 |
| March 17, 2015 | VAI | Human Drugs · Drug Quality Assurance | 921536 |
| September 7, 2012 | VAI | Human Drugs · Drug Quality Assurance | 800507 |
| January 7, 2011 | NAI | Human Drugs · Drug Quality Assurance | 709986 |
FDA documents
People (4)
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Company Information
Name
Gland Pharma Limited
FEI Number
3002647489
Address
Survey 143-148 150-151 Gandimaisamma, Cross Road, D P Pally, Quthubullapur Medchal-Malkajgiri District, Hyderabad, India
Country
India
ID: dd730d79-1c97-4fb0-b717-c0ebd71a5b3f