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The US health regulator has issued 13 observations, to Alkem Laboratories Daman facility and 1 to US plant.
The inspection was conducted by the regulator, at the Amaliya, Daman manufacturing facility during March 19-27,2018. Following the inspection, it has received a Form 483 with thirteen observations from US Food and Drug Administration (USFDA) for Daman facility.
Furthermore, the US FDA had also conducted an inspection at its manufacturing facility in USA during March 12-16, 2018 and issued one Form 483 observation.
Alkem stated, “The company will put together a detailed response with adequate corrective and preventive measures to address the US FDA observations and the same is proposed to be filed within the timeline stipulated by the USFDA.”
