Company
IndiaJubilant Generics Limited, Roorkee, India – FDA Inspections
Inspection records and compliance data for Jubilant Generics Limited in Roorkee. 10 FDA inspections on record (4 OAI), 2 Form 483s, 1 warning letter, last inspected August 01, 2025.
Company Profile
This profile covers Jubilant Generics Limited based in Roorkee, India.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 4
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected March 1, 2013. Last inspected August 1, 2025.
Most cited issue areas
- Investigations of discrepancies, failures3 inspections
- Equipment Design, Size and Location2 inspections
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 1, 2025 | OAI | Human Drugs · Generic Drug Evaluation | 1278253 |
| February 2, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1231774 |
| August 1, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1175958 |
| March 12, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1137148 |
| November 6, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1112459 |
| August 8, 2018 | Not classified | Human Drugs · Generic Drug Evaluation | 1061441 |
| March 23, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1007262 |
| April 8, 2016 | VAI | Human Drugs · Drug Quality Assurance | 971357 |
| March 13, 2015 | VAI | Human Drugs · Drug Quality Assurance | 921700 |
| March 1, 2013 | VAI | Human Drugs · Drug Quality Assurance | 837396 |
FDA documents
People (6)
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Company Information
Name
Jubilant Generics Limited
FEI Number
3006895982
Address
Bhagwanpur, Roorkee, India
Country
India
ID: 0e33a821-8bc0-4f36-9264-5a108f087380