Company
IndiaZydus Lifesciences Limited, Matoda, India – FDA Inspections
Inspection records and compliance data for Zydus Lifesciences Limited in Matoda. 10 FDA inspections on record (1 OAI), 5 Form 483s, last inspected November 13, 2025.
Company Profile
This profile covers Zydus Lifesciences Limited based in Matoda, India.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 1
- VAI
- 6
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 5
- Warning letters
- 0
First inspected October 4, 2012. Last inspected November 13, 2025.
Most cited issue areas
- Buildings not maintained in good state of repair1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Environmental Monitoring System1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 13, 2025 | VAI | Human Drugs · Generic Drug Evaluation | 1291548 |
| June 17, 2025 | Not classified | Human Drugs | 1277082 |
| March 27, 2024 | OAI | Human Drugs · Drug Quality Assurance | 1234298 |
| February 4, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1120399 |
| March 26, 2019 | VAI | Human Drugs · Generic Drug Evaluation | 1083911 |
| March 21, 2019 | VAI | Human Drugs · Bioresearch Monitoring | 1090219 |
| June 5, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1061074 |
| April 17, 2015 | VAI | Human Drugs · Drug Quality Assurance | 927576 |
| January 31, 2014 | VAI | Human Drugs · Drug Quality Assurance | 868910 |
| October 4, 2012 | VAI | Human Drugs · Drug Quality Assurance | 806239 |
FDA documents
People (6)
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Company Information
Name
Zydus Lifesciences Limited
FEI Number
3007621329
Address
Plot 1a, 8a Pharmez Special Economic Zone; Sarkhej-Bavla N H No, Matoda, India
Country
India
ID: 4904f62e-dd42-4ea9-b381-cb6e5d44558d