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Biocon Gets FDA Observations At Key Biosimilars Facilities

US Agency Finds Multiple Form 483 Deficiencies Across Bengaluru And Malaysia Sites

 
• By Dave Wallace

Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.

483 3D numbers green background
Biocon has received multiple Form 483 observations across three facilities • Source: Shutterstock

A US Food and Drug Administration inspection of key biosimilar manufacturing facilities for Biocon Biologics has resulted in the agency issuing multiple Form 483 observations of good manufacturing practice deficiencies across two sites in India and one in Malaysia.

“The US FDA conducted three on-site inspections of Biocon Biologics’ seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia,” Biocon noted in a BSE filing

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