FDA hits Lupin, Aurobindo and Cipla with Form 483s

Oct 15, 2019

India-based generic drugmakers Lupin, Aurobindo and Cipla recently received Form 483s from the U.S. Food and Drug after inspections in September. The FDA found issues related to cleanliness, out-of-specification results and more.

Lupin’s site in Tarapur, India, received three observations, while the FDA raised questions about the site’s batch production and control records. Lupin was also dinged for failures related to handling and storing cleaned utensils.

Aurobindo's site in Polepally, India, received seven observations, which included deficiencies in its Out of Specification results. The FDA also found issues with Aurobindo’s its approach to commercial process validation. 

Cipla’s site in Goa, India, received 12 observations, which included cleaning-related issues and aseptic-processing issues.

Read the RAPS report