Biocon announced that the USFDA 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 Biocon's Oral Solid Dosage Facility conducted between 11 February - 15 February 2019.
The pre-approval inspection of the company's additional, new injectable manufacturing line for a biologic drug product, conducted between 7 February - 15 February 2019, resulted in a Form 483 with two observations.
Biocon intends to address these expeditiously.
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