Biocon says it has responded to all USFDA observations
Biocon said the company has already responded to USFDA on all observations of the recent audit within stipulated timelines
New Delhi: Biotechnology major Biocon has received observations from US health regulator pertaining to issues over manufacturing practices, which the company said have been responded to.
“Biocon has already responded to USFDA (US Food and Drug Administration) on all observations of the recent audit within stipulated timelines,” the company said in a regulatory filing. The company was responding to reports that the US health regulator has issued observations under Form 483 highlighting issues related to quality control tests and sampling during manufacturing at its Bengaluru facility.
As per the USFDA, an “FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts”.
It notifies the company’s management of objectionable conditions. Biocon, however, did not specify the nature of issues raised by the USFDA, saying, “As a policy we do not comment on any schedule or outcomes of regulatory inspections, unless we believe that there is a material impact”.
It further said: “Observations on Form 483 is a standard outcome of any audit.” Shares of Biocon Ltd were trading at Rs1,009.15 apiece in the afternoon trade, down 3.62% from the previous close on BSE.