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Glenmark Baddi facility gets 6 USFDA observations
New Delhi: Drugmaker, Glenmark Pharmaceuticals Ltd, has recently announced that the US Food and Drug Administration (USFDA) has issued Form 483 with six observations after an inspection at the Company's formulation manufacturing facility based out of Baddi, India.
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 between June 13, 2022 and June 22, 2022.
Read also: Alkem Labs gets 3 USFDA observations for St Louis facility
"The Company is committed to undertake all necessary steps required to address their observations at the earliest," Glenmark said in a BSE filing.
"The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," the company stated.
Read also: Glenmark Pharma gets 5 USFDA observations for Goa facility
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