USFDA issues EIR for Alkem Labs Baddi facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-06-25 11:18 GMT | Update On 2024-06-25 11:18 GMT
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Mumbai: Alkem Labs has informed in a BSE filing that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the manufacturing facility of the Company located at Baddi, India.
The Inspection has been classified as Voluntary Action Indicated (VAI) and has been closed accordingly.
The USFDA had conducted inspection from 19th March, 2024 to 27th March, 2024 and issued Form 483 with ten observations.
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