FDA OKs Alkem’s Corrective Action Plan for API Manufacturing Facility

The US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to Alkem Laboratories, a Mumbai, India-headquartered pharmaceutical company, for Alkem’s active pharmaceutical ingredient (API) facility in Ankaleshwar, India and has reviewed and found acceptable Alkem’s corrective and preventative action (CAPA) plan for the facility.

The EIR indicates that the FDA inspection of the API facility, which occurred on December 5-9, 2016, was closed in March 2017. Based on the inspection, the FDA had issued Alkem a Form 483 with three observations. The company’s CAPA plan was submitted to the FDA within the agency’s stipulated timelines.

In addition to the December 2016 inspection at Alkem’s API facility in Ankaleshwar, the FDA also conducted an inspection of another Alkem manufacturing facility in Baddi, India on March 2-10, 2017. Based on this inspection, the FDA also issued a Form 483 with three observations, for which Alkem is preparing CAPA measures to address the FDA’s observations.

Source: Alkem Laboratories for Ankaleshwar facility and Baddi facility

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