U.S. FDA has issued Form 483 with six observations after an inspection at Glenmark Pharma's formulation manufacturing facility based out of Baddi, India between June 13, 2022 and June 22, 2022.
Harish Kuber, Company Secretary & Compliance Officer, Glenmark Pharma said, The Company is committed to undertake all necessary steps required to address their observations at the earliest. The Company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe.
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. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant.
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