Drug firm Alkem Laboratories today said the US health regulator has inspected its Baddi plant and issued three observations on account of violation of good manufacturing norms.
The US Food and Drug Administration (USFDA) inspected the plant from March 2 to March 10 and has issued an inspection report to the company which contains three 483 observations, Alkem Laboratories said in a regulatory filing.
"The company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA observations and the same is proposed to be filed within the time line stipulated by USFDA," it added.
The company's plant in Baddi, Himachal Pradesh manufactures finished formulations.
As per the USFDA, 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 injurious to health.
The FDA Form 483 notifies the company's management of objectionable conditions.
Alkem Laboratories shares today ended 0.22 per cent down at Rs 1,972.55 on the BSE.
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