Company
IndiaGland Pharma Limited, Units I+II Pashamylaram Site, Hyderabad, India – FDA Inspections
Inspection records and compliance data for Gland Pharma Limited, Units I+II Pashamylaram Site in Hyderabad. 7 FDA inspections on record, 4 Form 483s, last inspected August 02, 2024.
Company Profile
This profile covers Gland Pharma Limited, Units I+II Pashamylaram Site based in Hyderabad, India.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 5
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 4
- Warning letters
- 0
First inspected September 18, 2015. Last inspected August 2, 2024.
Most cited issue areas
- Procedures for sterile drug products2 inspections
- Complaint Handling Procedure1 inspection
- Environmental Monitoring System1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2024 | Not classified | Human Drugs · Drug Quality Assurance | 1244660 |
| August 26, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1216053 |
| June 27, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1210478 |
| November 7, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1109239 |
| May 29, 2018 | Not classified | Human Drugs | 1057719 |
| February 23, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1043371 |
| September 18, 2015 | VAI | Human Drugs · Drug Quality Assurance | 944183 |
FDA documents
People (4)
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Company Information
Name
Gland Pharma Limited, Units I+II Pashamylaram Site
FEI Number
3009864167
Address
54 55 64 - 68 Plots 42 - 52, Sy No 166; 171 172 - 177 Sangareddy Dist, Hyderabad, India
Country
India
ID: a7dffca3-c5cc-4802-9cab-54995e7133ca