Biocon’s insulin production facility in Malaysia has received a US FDA Form 483 with eight observations concerning operational procedures and training programs. The US Food and Drug Administration (FDA) inspected Indian biopharma giant Biocon’s manufacturing facility in Malaysia between July 10 and July 20. The site produces regular, basal, and rapid insulins, including its biosimilar insulin product, which is a follow-on insulin glargine referencing Sanofi’s Lantus. The 10-page FDA report details eight observations, ranging  from issues with cleanliness, drug product…