USFDA issues ten observations for Alkem Labs Baddi facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-03-28 05:59 GMT | Update On 2024-03-28 05:59 GMT
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Mumbai: Alkem Labs has announced that the U.S. Food and Drug Administration (USFDA) has issued Form 483 with ten observations at the end of the inspection at the Company’s manufacturing facility located at Baddi.
USFDA inspected the facility from 19th March, 2024 to 27th March, 2024. This was a GMP as well as a Pre-Approval Inspection.
"There is no data integrity observation. This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," the Company stated in a BSE filing.
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