Biocon gets 3 USFDA observations for insulin facility in Malaysia

USFDA had conducted a pre-approval inspection of Biocon's subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for Insulin Glargine between February 10 and 21. "At the conclusion of the inspection, the agency issued a Form 483 with three observations which we believe are procedural in nature," a Biocon spokesperson said in a regulatory filing.
Source: The Economic Times Healthcare and Biotech News - Category: Pharmaceuticals Source Type: news