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.
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