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Alkem got EIR from the US FDA

 

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US FDA has issued an Establishment Inspection Report (EIR) for Alkem Labs's Ankaleshwar API Facility which was inspected in December 2016. The inspection has now been closed by the US FDA.

The US FDA had inspected the Ankaleshwar API manufacturing facility from 5th to 9th December, 2016 and had issued Form 483 with three (3) observations.

 

Post this, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The US FDA has reviewed the CAPA and has found them acceptable.

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