Alkem Labs Gets Three Observations From U.S. FDA For St. Louis Facility
Drug firm Alkem Laboratories Ltd. on Friday said it has received three observations from the American health regulator after inspection of its facility at St. Louis in the U.S.
The United States Food and Drug Administration had conducted an inspection of the company's manufacturing facility located at St. Louis, U.S.A. from Jan. 27 to Feb. 6, 2020, Alkem Laboratories said in a filing to the BSE.
"At the end of the inspection, the company has received Form 483 with three observations," it added.
The company shall submit to the U.S. FDA within the stipulated timeline a detailed response to close out all the observations associated with this inspection, Alkem Laboratories said.
An FDA Form 483 notifies a company's management of objectionable conditions at the facility inspected by the U.S. health regulator.