USFDA successfully concludes inspection at Alkem Labs Taloja Bioequivalence Center

Maharashtra: Alkem Labs has recently announced the successful completion of the U.S. Food and Drug Administration (USFDA) inspection of its Taloja facility in Maharashtra.

The inspection was conducted from 11th April to 14th April 2022.

"This is to inform you that USFDA had conducted an inspection at the Company's Bioequivalence Center located at Taloja, Maharashtra from 11th April, 2022 to 14th April 2022," the company said in a BSE filing.

At the end of the inspection, no Form 483 was issued, it added.

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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Established in 1973 and headquartered in Mumbai, Alkem is a Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.