The US Food and Drug Administration (USFDA) had conducted an inspection of the company's facility at St Louis, US, from January 14 to February 5, this year in a phased manner, Alkem said in a regulatory filing.
"At the end of inspection, the company has received Form 483 that contains eight observations," it added.
The company shall submit a detailed response to the USFDA, within the stipulated timeline, with a suitable corrective and preventive measures to address the observations, Alkem Laboratories said.
Shares of the company were trading 0.66 per cent down at Rs 1,882.35 on the BSE.
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