USFDA gives 8 observations to Alkem Laboratories for St Louis facility

Drug firm Alkem Laboratories Wednesday said the US health regulator has issued eight observations after inspecting its manufacturing plant at St Louis. 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 the 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.