USFDA issues 2 observations for Alkem Labs St Louis facility

Written by Ruchika Sharma Published On 2022-09-17T10:30:45+05:30 | Updated On 17 Sept 2022 10:31 AM IST

USFDA issues 2 observations for Alkem Labs St Louis facility

Maharashtra: Alkem Labs has recently announced that the US Food and Drug Administration (USFDA) has issued two observations after a pre-approval inspection at the Company's manufacturing facility located at St. Louis, USA.

The inspection was conducted from 06th September 2022 to 14th September 2022.

"At the end of the inspection, the Company has received Form 483 with two (2) observations. There is no data integrity observation," the company stated in a recent BSE filing.

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 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," Alkem added.

Medical Dialogues team had earlier reported that the US Food and Drug Administration (USFDA) had issued Form 483 with 3 observations after an inspection at the Company's St. Louis manufacturing facility.

Read also: Alkem Labs gets 3 USFDA observations for 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. The company's portfolio includes illustrious brands like Clavam, Pan, Pan-D and Taxim-O.

Akem has 20 manufacturing facilities at multiple locations in India and the United States of America.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751