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Alkem Laboratories has said the US Food and Drug Administration (USFDA) has pointed out 14 observations for objectionable conditions at its manufacturing units at Amaliya in Daman and St Louis in the US.
The USFDA had conducted an inspection at the Daman unit from March 19-27, 2018, Alkem Laboratories said in a regulatory filing today.
“Post the inspection, the company has received a Form 483 with 13 observations,” it added.
As per the USFDA, Form 483 notifies the company’s management of objectionable conditions based on observations made by its investigators about the 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 USFDA observations and the same is proposed to be filled within the timeline stipulated by the USFDA,” Alkem said.
The company further said the USFDA 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 USFDA, it has submitted a detailed corrective and preventive action plan to the regulator within the stipulated timeline, Alkem said.
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