Glenmark receives 6 USFDA observations for Baddi facility
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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.
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