US FDA inspection at Alkem's manufacturing facility located at St. Louis, USA

US FDA had conducted a Pre-Approval inspection at the Company's manufacturing facility located at St. Louis, USA 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.

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.

Source : Equity Bulls

Keywords

AlkemLaboratories USFDA PreApprovalInspection StLouis Form483 2Observations