Biocon notification to the stock exchange
“The U.S. Food and Drug Administration (US-FDA) conducted three on-site
inspections of Biocon Biologics’seven manufacturing facilities spanning two sites
in Bengaluru, India and one at Johor, Malaysia. These inspections started with the
Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August
30, 2022.
Outcome: The agency issued form 483s with 11 observations each for the 2 sites in Bangalore and 6 observations for the site in Malaysia
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