Alkem Laboratories Gets Two Observations From USFDA For Baddi Facility

New Delhi: Pharmaceutical firm Alkem Laboratories on Friday said it has received two observations from the US health regulator after inspection of its Baddi facility in Himachal Pradesh.

The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s manufacturing facility at Baddi from February 17 to 21, 2020, Alkem Laboratories said in a BSE filing.

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

The company shall put together a detailed response with adequate corrective and preventive measures to address the observations and the same is proposed to be filed within the timeline stipulated by the US health regulator.

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