About Biocon Our Business Research & Development Biocon's Technology Investors Media Careers CSR
  Press Releases
  Download Center
  Video Gallery
  Photo Gallery
  Media Contacts

Company Statement

U.S. FDA Completes Pre-Approval Inspection of Two New Biocon Biologics Facilities in Bengaluru

Bengaluru, Karnataka, India, Sep 20, 2019

"The U.S. FDA conducted a Pre-Approval Inspection (PAI) at two of our new Biologics Manufacturing facilities in Bengaluru from Sep 10 to Sep 19, 2019. The inspection included a new Drug Substance (DS) and a Drug Product (DP) unit.

At the conclusion of the inspection we received a Form 483 with four observations for the new DS facility, three observations for the new DP facility and one general observation. We are confident of addressing these observations effectively through a Corrective and Preventive Action (CAPA) plan, expeditiously. The Pre-Approval Inspection of our new facilities does not have any impact on our current commercialization plans from our existing facilities."

- Company Spokesperson

<< Back


Download the
Company Statement


Recommended sites Biocon on  
About Us

Investor Relations
Media Relations
Site Map
Contact Us
Our Growth Accelerators
Fact Sheet
Branded Formulations
Research Services
Active Discovery Program

Karnataka Vision Group on BT
Syngene International
Biocon Academy

    Linked In   
  Report adverse event/side effects and product complaints    
  * Disclaimer            © 2018, Biocon. All Rights Reserved