Mumbai: Alkems Laboratories has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with 3 observations after an inspection at the Company’s St. Louis manufacturing facility.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The inspection was conducted from 06th June, 2022 to 17 th June, 2022.
“This is to inform you that US FDA had conducted an inspection of the Company’s
manufacturing facility located at St. Louis, USA from 06th June, 2022 to 17
th June, 2022,” the company said in a BSE filing.
“The Company shall submit to US FDA within the stipulated timeline, a detailed response to
close out all the observations associated with this inspection,” the company further stated.
Medical Dialogues Team had earlier reported that Alkem Labs had received two observations from USFDA for its St. Louis manufacturing facility.
Alkem Labs is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company was founded by Samprada Singh in 1973. The company’s portfolio includes illustrious brands like Clavam, Pan, Pan-D and Taxim-O.