Alkem Laboratories announced on Thursday that the US Food and Drug Administration had inspected its Taloja facility in Maharashtra and found “zero” issues.
From July 26-28, 2021, the US Food and Drug Administration (USFDA) conducted a remote and virtual bio-analytical inspection of Alkem Laboratories’ Bioequivalence Center in Taloja, Maharashtra, according to 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.
Shares of Alkem Laboratories were trading 0.30 percent lower at Rs 3,362.05 apiece on BSE.
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