Alkem’s manufacturing facility at Baddi receives two observations from USFDA

The USFDA had conducted an inspection at Alkem Laboratories Limited’s manufacturing facility located at Baddi, India from February 17, 2020 to February 21, 2020. At the end of inspection, the company has received a Form 483 with two observations. 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 filed within the timeline stipulated by USFDA.