Alkem Labs gets 1 observation from USFDA for Indore facility
New Delhi: Alkem Laboratories Limited has recently announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with one observation after inspecting its Indore facility.
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.
The inspection was conducted from 01st July 2022 to 07th July 2022.
"This is to inform you that USFDA had conducted a GMP and Pre-Approval inspection at the Company's manufacturing facility located at Indore from 01st July, 2022 to 07th July, 2022," Alkem said in a BSE filing.
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At the end of the inspection, the Company has received Form 483 with one observation with respect to Abbreviated New Drug Application (ANDA) filed for the products to be manufactured at the said plant. There is no data integrity observation.
"This GMP and Pre-Approval Inspection is part of the routine business operations and the Company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said observation," Alkem labs added.
Alkem Labs is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, India. The company was founded by Samprada Singh in 1973. The company's portfolio includes illustrious brands like Clavam, Pan, Pan-D and Taxim-O.
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