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.
“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.