Company
IndiaApotex Research Private Limited, Bengaluru, India – FDA Inspections
Inspection records and compliance data for Apotex Research Private Limited in Bengaluru. 8 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected March 15, 2024.
Company Profile
This profile covers Apotex Research Private Limited based in Bengaluru, India.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 5
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected April 17, 2010. Last inspected March 15, 2024.
Most cited issue areas
- Absence of Written Procedures2 inspections
- Procedures not in writing, fully followed2 inspections
- Investigations of discrepancies, failures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 15, 2024 | VAI | Human Drugs · Generic Drug Evaluation | 1233067 |
| February 2, 2019 | NAI | Human Drugs · Bioresearch Monitoring | 1081769 |
| November 17, 2017 | Not classified | Human Drugs | 1035038 |
| May 20, 2016 | VAI | Human Drugs · Drug Quality Assurance | 970670 |
| July 1, 2014 | OAI | Human Drugs · Drug Quality Assurance | 886801 |
| July 12, 2013 | VAI | Human Drugs · Drug Quality Assurance | 851564 |
| June 22, 2012 | VAI | Human Drugs · Drug Quality Assurance | 801824 |
| April 17, 2010 | VAI | Human Drugs · Drug Quality Assurance | 659921 |
FDA documents
Warning Letters (1)
Other regulators (1)
People (6)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Apotex Research Private Limited
FEI Number
3006076314
Address
2 Plots 1, Bommasandra Jigani Link Rd; 4th Phase, Bengaluru, India
Country
India
ID: 074db0b0-4f5f-4ee7-90e9-1c661c86f90c