Biocon a leading Biotechnology Company said US Food and Drug Administration has completed a pre-approval inspection of Biocon's sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations.
The observations are largely procedural and aimed at continuous improvement. The company will respond to the USFDA with a corrective and preventive action plan in a timely manner, the company said in a filing with BSE.
Besides, the company has received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bangalore in March 2018. The report lists 6 major observations with no observation classified as critical. The company will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period, the filing said. (UNI)