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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....
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.
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.
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.
Read also: Alkem Labs gets 1 observation from USFDA for Indore facility
Ruchika Sharma joined Medical Dialogue as an Desk Editor 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