USFDA issues Form 483 with 8 observations to Lupin Mandideep plant

United States Food and Drug Administration (USFDA) has inspected Lupin’s Mandideep Unit-1, Bhopal, Madhya Pradesh facility from November 14, 2022 to November 23, 2022. 

The inspection of the facility closed with issuance of a Form 483 with eight observations each for the drug product facility and active pharmaceutical ingredients (APIs) facility at the site. 

Lupin pharmaceutical company said We are committed to addressing the observations and will work with the U.S. FDA to resolve these issues at the earliest.

We uphold quality and compliance issues with utmost importance and remain committed to be compliant with current good manufacturing practice (cGMP) quality standards across all our facilities.

Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) in over 100 markets in the U.S, India, South Africa, and across the Asia Pacific, Latin America, Europe, and Middle East regions.

USFDA issues Form 483 with 8 observations to Lupin Mandideep plant: