USFDA inspection ends with ‘Zero’ observations: Alkem

At the end of the inspection, no form 483 was issued, the company added.

Picture: Pixabay

Last Updated on August 1, 2021 by The Health Master

Drug firm Alkem Laboratories yesterday said the US health regulator has conducted an inspection of its Taloja facility in Maharashtra, and it ended with ‘zero’ observations.

The US Food and Drug Administration (USFDA) had conducted a remote and virtual bio-analytical inspection of the company’s Bioequivalence Center located at Taloja, Maharashtra from 26th to 28th July, 2021, Alkem Laboratories said in a regulatory filing.

At the end of the inspection, no form 483 was issued, the company added.

A form 483 is issued by the USFDA to notify a company’s management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.

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