cGMPs

FDA issues six observations for Lupin plant

Jan 31, 2019

The U.S. FDA has issued six observations after the inspection of Lupin's Pithampur facility in Madhya Pradesh (central India).

The inspection of Pithampur Unit -2 was carried out by the agency between January 14 and January 25, 2019. Lupin did not provide details about the nature of the observances.

In 2017, the FDA had sent Lupin a warning letter about this same facility, citing issues with product testing, specifically noting that employees had disregarded out-of-spec results.

Read the press release