Alkem Laboratories announced that US FDA had conducted a Pre-Approval inspection at the Company's manufacturing facility located at St. Louis, USA from 31 October 2022 to 09 November 2022. At the end of the inspection, the Company has received Form 483 with three (3) observations. There is no data integrity observation.
This Pre-Approval 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.
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