USFDA issues Form 483 with 7 observations to Biocon’s sterile drug facility in Bangalore

03 May 2018 Evaluate

The US Food and Drug Administration (USFDA) has completed a pre-approval inspection of Biocon’s sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations. The observations are largely procedural and aimed at continuous improvement. The company will respond to the USFDA with a corrective and preventive action plan in a timely manner.

Besides, the company has received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bangalore in March 2018. The report lists 6 major observations with no observation classified as critical. The company will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

Biocon Share Price

366.40 -6.25 (-1.68%)
23-Jan-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1631.65
Dr. Reddys Lab 1235.15
Cipla 1314.85
Zydus Lifesciences 881.95
Lupin 2137.15
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×