Alkem Labs gets 3 USFDA observations for St Louis facility

Mumbai: Indian multinational pharmaceutical company, Alkem Labs, has recently announced that the company has received Form 483 with three (3) observations from the US Food and Drug Administration (USFDA) at the end of the Pre-Approval inspection of its St. Louis 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.

"This is to inform you that US FDA had conducted a Pre-Approval inspection at the Company's manufacturing facility located at St. Louis, USA from 31st October, 2022 to 09th November 2022," the company stated in a BSE filing.

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There is no data integrity observation. This Pre-Approval Inspection is part of the routine business operations, and the Company shall submit to USFDA, within the stipulated timeline, a detailed response to close out the said observations.

Medical Dialogues team had earlier reported that the US Food and Drug Administration (USFDA) had issued two observations after a pre-approval inspection at the Company's manufacturing facility located in St. Louis, USA.

Read also: USFDA issues 2 observations for Alkem Labs St Louis facility

Alkem Labs is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company was founded by Samprada Singh in 1973. Alkem manufacturing operations are focused on producing generics, branded generics, over-the-counter (OTC) products, Active Pharmaceutical Ingredients (APIs), and nutraceuticals. The company's portfolio includes illustrious brands like Clavam, Pan, Pan-D, and Taxim-O.

Alkem has an extensive manufacturing footprint which has a total of 21 manufacturing facilities, out of which 19 are in India, and 2 are in the United States. It has various manufacturing facilities at Daman, Baddi, Indore, and Sikkim.   

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