Alkem Labs St Louis facility gets 3 USFDA observations
New Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received three observations from the US health regulator for its manufacturing facility located at St. Louis, the USA after the closure of the inspection conducted by the regulator.
The facility was inspected from January 27 to February 6, 2020.
"The United States Food and Drug Administration (USFDA) had conducted an inspection of the company's manufacturing facility located at St. Louis, USA from January 27 to February 6, 2020," Alkem Laboratories said in a filing to the BSE.
The drugmaker stated that it has received three observations from the American health regulator after inspection of its facility at St Louis in the US.
"At the end of the inspection, the company has received Form 483 with three observations," it added.
The company shall submit to the USFDA within the stipulated timeline a detailed response to close out all the observations associated with this inspection, Alkem Labs further added.
Established in 1973, Alkem Laboratories has a portfolio of over 700 brands covering all major therapeutic segments. It has 16 manufacturing facilities, 14 being in India and two in the United States.