Comments
Biocon has said that the US health regulator has made six observations after inspecting its Malaysia manufacturing facility.
“The USFDA has completed a pre-approval inspection of our manufacturing facility in Malaysia and issued Form 483 with six observations,” Biocon said in a regulatory filing today.
“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 at 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 down by 2.12 per cent at Rs 560.20 on the BSE.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.