Corporate News     15-Sep-22
Alkem's St. Louis unit undergoes USFDA pre-approval inspection
Receives Form 483 with two observations
Alkem Laboratories announced that US FDA had conducted a Pre-Approval inspection at the Company's manufacturing facility located at St. Louis, USA from 06 September 2022 to 14 September 2022. At the end of the inspection, the Company has received Form 483 with two (2) 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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