Alkem Laboratories announced that USFDA had performed a Pre-Approval inspection on the Company’s production facility positioned at St. Louis, USA from September 6, 2022 to September 14, 2022. At the cease of the inspection, the Company has received Form 483 with two (2) observations. There is no facts integrity statement.
This Pre-Approval Inspection is a part of the recurring business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed reaction to shut out the stated observations.
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