USFDA inspection at Lupin with 2 observations

United States Food and Drug Administration issues 2 observations after inspection of Lupin Pharmaceuticals at its Madya Pardesh facility

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USFDA
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New Delhi: Drug firm Lupin on said the US health regulator has issued two observations after inspection of the company’s Madhya Pradesh facility.

The inspection of the company’s Pithampur Unit-I facility by the United States Food and Drug Administration (USFDA) has been completed, Lupin said in a filing to BSE.

The inspection, carried out between February 3 and February 11, 2020, closed with two 483 observations, it added.

An FDA Form 483 is issued to a 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.

Also read: Alkem Lab gets three observations from USFDA

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

“We uphold the highest standards of quality and compliance across our manufacturing operations and are committed to consistently produce and distribute products of the highest quality,” Lupin MD Nilesh Gupta said.

Shares of Lupin closed at Rs 702.35 per scrip on BSE, down 0.36 per cent from the previous close.

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