Express Pharma

Alkem Labs gets 14 US FDA observations for two units


The US FDA had conducted an inspection at the Daman unit from March 19-27, 2018

Alkem Laboratories said the US Food and Drug Administration (US FDA) has pointed out 14 observations for objectionable conditions at its manufacturing units at Amaliya in Daman and St Louis in the US following inspections. The US FDA had conducted an inspection at the Daman unit from March 19-27, 2018, Alkem Laboratories said in a regulatory filing.

“Post the inspection, the company has received a Form 483 with 13 observations,” it added.

As per the US FDA, Form 483 notifies the company’s management of objectionable conditions based on observations made by its investigators about conditions or practices which would “indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”

“The company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA observations and the same in proposed to be filed within the timeline stipulated by the US FDA,” Alkem said.

The company further said the US FDA had also conducted an inspection at its manufacturing unit at St Louis from March 12015, 2018. In response to one Form 483 observation issued by the US FDA, it has submitted a detailed corrective and preventive action plan to the regulator within the stipulated timeline, Alkem said.

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