USFDA issues 10 observations after inspection of Lupin manufacturing facility

31 Mar 2023 , 09:37 AM

Lupin announced on Thursday that its manufacturing facility in Pithampur Unit-2 was inspected by the US Food and Drug Administration (USFDA) from March 21 to March 29, 2023. As a result of the inspection, the USFDA issued a Form-483 containing ten observations.

Lupin stated in a regulatory filing that following the inspection, the issuance of a Form-483 with ten observations concluded the process.

The company also stated that it is taking comprehensive measures to address the observations and will collaborate with the USFDA to resolve the issues as soon as possible.

Following an inspection, the United States Food and Drug Administration (FDA) issues a Form 483 to the management of a company if any observations are made that suggest the presence of conditions that may be deemed violative of the Food Drug and Cosmetic (FD&C) Act and its associated legislation.

Lupin’s Mandideep-based manufacturing facility received a Form-483 with eight observations each for its product and raw material production centers from the USFDA in November of last year.

At around 9.36 AM, Lupin was trading 1.79% lower at Rs641.20, against the previous close of Rs652.40 on NSE. The counter opened at Rs644.65.

For feedback and suggestions, write to us at [e-mail]