Company
IndiaZYDUS LIFESCIENCES LIMITED, Ahmedabad, India – FDA Inspections
Inspection records and compliance data for ZYDUS LIFESCIENCES LIMITED in Ahmedabad. 12 FDA inspections on record (3 OAI), 1 Form 483, last inspected January 27, 2023.
Company Profile
This profile covers ZYDUS LIFESCIENCES LIMITED based in Ahmedabad, India.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 3
- VAI
- 3
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 6, 2009. Last inspected January 27, 2023.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Investigations of discrepancies, failures2 inspections
- Air filtration system lacking in production area1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 27, 2023 | Not classified | Human Drugs | 1199182 |
| August 5, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1177670 |
| May 3, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1088772 |
| March 22, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1090231 |
| February 9, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1047493 |
| September 7, 2017 | Not classified | Human Drugs | 1030582 |
| February 16, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1006533 |
| September 5, 2014 | OAI | Human Drugs · Drug Quality Assurance | 895756 |
| August 19, 2013 | VAI | Human Drugs · Drug Quality Assurance | 850780 |
| February 23, 2012 | VAI | Human Drugs · Drug Quality Assurance | 772764 |
| February 3, 2011 | OAI | Human Drugs · Drug Quality Assurance | 709477 |
| February 6, 2009 | NAI | Human Drugs · Drug Quality Assurance | 575706 |
FDA documents
People (6)
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Company Information
Name
ZYDUS LIFESCIENCES LIMITED
FEI Number
3002984011
Address
419&420 Survey No 417, Ahmedabad, India
Country
India
ID: aa40e2a7-c250-4524-b05f-6ca311474c5c