USFDA says Lupin did not address 4 of its previous observations

13 Apr 2023 , 12:16 PM

Lupin’s Pithampur plant was issued 10 observations recently on the conclusion of an inspection by the USFDA. The regulator says that out of which, 4 are repeat observations.

It is important to mention that the plant in question was inspected by the US Food and Drug Administration (USFDA) in January 2019, during which six observations were made. Furthermore, a warning letter had been sent to the facility in 2017.

The recent examination of Lupin’s Pithampur unit by the US Food and Drug Administration (USFDA) has brought to light apprehensions regarding the quality of the firm’s operations. 

Several of the USFDA’s observations, including inadequate reviews of discrepancies, failure to extend batch failure investigations to other products, and incomplete record-keeping of drug complaint investigations, have raised concerns about the company’s procedures.

Apart from the USFDA inspection, Lupin’s Pithampur plant was also assessed by the UK Medicines and Healthcare Products Regulatory Agency (UKMHRA), and the outcome of the inspection was satisfactory. 

The corporation has affirmed its unwavering dedication to upholding the most stringent quality standards and fulfilling all regulatory obligations.

At around 12.14 PM, Lupin’s stock was trading 0.91% lower at Rs 673.35, against the previous close of Rs 679.55 on NSE.

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