Bengaluru, Karnataka, India, May 05, 2017:
“With reference to Media Reports on USFDA 483s for Biocon, observations on form 483 is a standard outcome of any audit. Biocon has already responded to USFDA on all observations of the recent audit within stipulated timelines.
As a policy we do not comment on any schedule or outcomes of regulatory inspections, unless we believe that there is a material impact. Biocon has a good track record of inspections by the USFDA, European regulators and other regulators from developed and emerging markets.”
– Company Spokesperson