USFDA issues 2 observations for Alkem Labs St Louis facility
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Maharashtra: Alkem Labs has recently announced that the US Food and Drug Administration (USFDA) has issued two observations after a pre-approval inspection at the Company's manufacturing facility located at St. Louis, USA.
The inspection was conducted from 06th September 2022 to 14th September 2022.
"At the end of the inspection, the Company has received Form 483 with two (2) observations. There is no data integrity observation," the company stated in a recent BSE filing.
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.
"This 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 observations," Alkem added.
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