News
4 Apr 2017
FDA now happy with Alkem's API facility
Company's CAPA addresses the three Form 483 observations.
Alkem Labs has announced that the FDA has issued an Establishment Inspection Record (EIR) for its Ankaleshwar API facility, which was inspected in December 2016.
The inspection has now been closed by the FDA. The FDA had inspected the Ankaleschwar API manufacturing facility from 5 to 9 December last year and had issued a Form 483 with three observations. Since then, the company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The FDA has reviewed the CAPA and has found them acceptable.
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