cGMPs / Generic

Mylan Hit with FDA Warning for Three Plants

Aug 19, 2015

According to U.S. FDA warning letter, generic giant Mylan is facing significant quality violations at three of its India manufacturing facilities.

The letter, dated August 6, cited "significant violations of current good manufacturing practice" including failure to establish and follow written procedures to prevent microbiological contamination, use of torn gloves, poor monitoring to ensure a contamination-free environment and a failure to investigate product complaints.

All three Bangalore plants cited by the FDA were acquired in Mylan’s 2013 purchase of Agila Specialties. The inspections were conducted in August and September of 2014 and February 2015.

The letter requires Mylan to complete all corrections and confirm cGMP compliance with the FDA, or the agency can withhold approval of new drug applications and refuse admission of products into the U.S.

Read the Bloomberg article

Read the FDA Warning Letter