USFDA issues 5 observations in Form 483 to Lupin's Nagpur Unit-2

31 Oct 2022 , 09:23 AM

Lupin Limited informed that USFDA conducted an inspection on Lupin’s Nagpur Unit-2 injectable manufacturing facility from October 17, 2022, to October 29, 2022.

The injection facility was subjected to a Pre-Approval Inspection. The inspection concluded with the issuance of a Form-483 containing five observations.

The company stated that it is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing in the U.S.

According to the US Food and Drug Administration (USFDA), Form 483 is issued to a company’s management at the end of an inspection if the investigator notices any conditions that may indicate violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts.

At around 9.26 AM, Lupin was at Rs701.50 up by 0.73% from its previous closing of Rs696.40 on the BSE. The scrip opened at Rs696.40 and touched intraday high and low of Rs705.05 and Rs689.10 respectively. 

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