Alkem Labs gets USFDA EIR for Mandva facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-29 06:24 GMT | Update On 2024-03-21 09:52 GMT
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Mumbai: Alkem Labs has announced that US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the Company's API manufacturing facility located at Mandva.
The Inspection has been classified as Voluntary Action Indicated (VAI) and was closed accordingly.
Medical Dialogues team had earlier reported that Alkem Labs had received Form 483 with three observations from the USFDA at the end of the inspection conducted at the Company’s API manufacturing facility located at Mandva.
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