Alkem Labs gets two USFDA observations

Alkem Laboratories Ltd has received two observations from US Food and Drug Administration (FDA) for the company's facility in Baddi, Himachal Pradesh.

715
USFDA
Picture: Pixabay
< 1 min. read

Alkem Laboratories Ltd has received two observations from US Food and Drug Administration (FDA) for the company’s facility in Baddi, Himachal Pradesh.

“US FDA had conducted an inspection at the company’s manufacturing facility located at Baddi, India from 17th to 21st February 2020,” the company said in a filing.

Also read: USFDA inspection of Lupin with no observation

“At the end of inspection, the company has received a Form 483 with two observations,” the company added.

The company said it 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 US FDA.

LEAVE A REPLY

Please enter your comment!
Please enter your name here