Biocon has made public in a filing with the BSE that it has received a Form 483 from the U.S. FDA. In the 483 inspectors from the regulatory agency, which were on-site from June 24thto July 5th, noted no fewer than 12 observations at three of the biopharma company’s units in Malaysia. However, as of this writing, details of these observations have not been made public. The units noted in the 483 are insulin glargine drug substance, drug product and device assembly facilities. Learn More