Bengaluru, India, Feb 18, 2019
"This is to inform you that the U.S. FDA concluded two pre approval inspections of Biocon’s manufacturing facilities in Bengaluru.
There were no observations and no Form 483 was issued after the pre-approval inspection of our Oral Solid Dosage Facility conducted between 11th-15th Feb 2019.
The pre-approval inspection of our additional, new injectable manufacturing line for a biologic drug product, conducted between 7th-15th Feb 2019, resulted in a form 483 with two observations. Biocon intends to address these expeditiously.
We remain committed to global standards of Quality and Compliance."
- Company Spokesperson