FDA issues 17 observations for Biocon Biologics’ manufacturing facilities

Biocon Biologics announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab.  Biocon Biologics reported that the observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades.  Reportedly, Biocon Biologics does not expect the observations to impact current supply.