Biocon on Wednesday said it has received US FDA observations on Form 483 for its Bengaluru facility.
"Observations on Form 483 is a standard outcome of any audit,” Biocon spokesperson said in an email statement
"Biocon has already responded to US FDA on all observations of the recent audit within stipulated timelines," the statement added.
The company didn’t specify the nature of these observations.
"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," the company added.
CNBC-TV18 reported that Biocon has received eight observations for its Bengaluru unit. The observation related to lack of quality oversight in review steps followed in quality control tests, bio-burden sampling during manufacturing of drug product inadequate, among others.
The US drug regulator conveys its concerns on manufacturing practices through Form 483.
Companies that receive its observations must respond in writing with a corrective action plan and implement it quickly. If the company fails to meet the regulator’s expectations, a warning letter may be issued.
Shares of Biocon dropped 2.92 percent and were trading at Rs 1016.40 on BSE at 12 noon, the benchmark Sensex gained 0.78 percent to 30168.20 points.
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