Alkem Labs gets 2 USFDA observations for Baddi facility

PTI New Delhi | Updated on February 21, 2020 Published on February 21, 2020

Drug 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.

As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.

It notified the company’s management of objectionable conditions at the facility.

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Published on February 21, 2020
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