Bengaluru, India, May 02, 2018
"The US-FDA has completed a pre-approval inspection of our 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. We will respond to the FDA with a corrective and preventive action plan in a timely manner.
We have also this week received the preliminary report from the European Regulator post inspection of our sterile drug product facility in Bangalore in March 2018. The report lists 6 major observations with no observation classified as critical. We will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period."
- Biocon Spokesperson