US FDA details problems that led to Biocon’s Form 483 13-Mar-2020 By Ben Hargreaves The published Form 483 details five points of concern raised by inspectors to the company’s API facility in India.
Biocon hit with FDA 483 after inspection of API facility 06-Feb-2020 By Nick Taylor US FDA issues Form 483 to Biocon facility after preapproval and GMP inspections.