Company
IndiaSyngene International Ltd., Bengaluru, India – FDA Inspections
Inspection records and compliance data for Syngene International Ltd. in Bengaluru. 6 FDA inspections on record, 1 Form 483, last inspected February 20, 2025.
Company Profile
This profile covers Syngene International Ltd. based in Bengaluru, India.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 18, 2013. Last inspected February 20, 2025.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 20, 2025 | Not classified | Animal Drugs & Feeds, Human Drugs | 1267516 |
| November 15, 2022 | NAI | Animal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives | 1193108 |
| August 21, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1103377 |
| April 27, 2018 | Not classified | Human Drugs | 1056484 |
| July 11, 2014 | NAI | Human Drugs · Drug Quality Assurance | 890834 |
| September 18, 2013 | NAI | Human Drugs · Drug Quality Assurance | 849300 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Syngene International Ltd.
FEI Number
3003600340
Address
Biocon Sez, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Park, Jigani Link Road, Bengaluru, India
Country
India
ID: 11ddfe19-cf6b-48b5-b7ab-8e3236ac3636