'The USFDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued a Form 483 with six observations," Biocon said in a regulatory filing.
"As per the normal expectations of the agency, we intend to respond with a corrective and preventive action plan in a timely manner," it added.
The company, however, did not share the details of the observations made by the US Food and Drug Administration (USFDA).
As per the US health regulator, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The USFDA Form 483 notifies the company's management of objectionable conditions.
Shares of Biocon were trading at Rs 561.30 apiece in the morning trade, down 1.93 per cent, from the previous close on BSE.