Alkem Laboratories Ltd. on Thursday said the U.S. health regulator has issued Form 483 with one observation after inspecting its facility at Indore in Madhya Pradesh.
As per U.S FDA, form 483 is issued to a firm's management after the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the food drug and cosmetic act and related acts.
The U.S. Food and Drug Administration had conducted a good manufacturing practice and pre-approval inspection at the company's Indore manufacturing facility from July, 1 2022 to July 7, 2022, Alkem Laboratories said in a regulatory filing.
"At the end of the inspection, the company has received Form 483 with one observation with respect to ANDA (Abbreviated New Drug Application) filed for the products to be manufactured at the said plant. There is no data integrity observation," it added.
"This GMP and pre-approval inspection is part of the routine business operations and the company shall submit to U.S. FDA within the stipulated timeline, a detailed response to close out the said observation," the company said.
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