Compliance Management / Generic / Small Molecule

India's Lupin Plant Slapped with a Form 483

Feb 24, 2015

Reuters

The U.S. FDA has issued Lupin a Form 483, listing six concerns of its production processes at a plant that produces both oral contraceptives and treatments for eye diseases for sale in the United States in Pithampur in central India.

According to a Reuters article, the FDA inspected the plant in January this year, after which it issued the company a Form 483. Lupin didn't disclose the nature of the observations. Read the full article