The US health regulator, has issued 7 observations to Biocon’s sterile drug product manufacturing facility in Bengaluru, after inspection.
In a filing to the BSE the company stated that, the USFDA has completed pre-approval inspection of the sterile drug product manufacturing facility in Benagaluru this week and issued a Form 483 with 7 observations. The observations are largely procedural and aimed at continuous improvement.
Further, the company has also received the preliminary report from the European Regulator post inspection of its sterile drug facility in Bengaluru in March 2018.
