Sunday, 15 April 2018

Detail information available on pharma minutes for Alkem Laboratories intimates of USFDA inspection of Daman facility

Receives 13 observations under Form 483
Alkem Laboratories announced that US FDA had conducted an inspection at the
Company's manufacturing facility located at Amaliya, Daman, India from 19 March, 2018 to 27 March, 2018.
Post the inspection, the Company has received a Form 483 with thirteen observations. The Company shall 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 US FDA.
Click here for details of 483 observation