Institute of Good Manufacturing Practices India®

Mylan's Indian Unit Received USFDA Warning Letter


Mylan NV received a warning letter from the U.S. FDA for failure in ensuring the purity of active pharmaceutical ingredients made at one of its plants in Pashamylaram, India.

The facility also fails to test the raw materials adequately.  Millions of blood pressure drugs, including some made by Mylan, were recalled two years ago after finding cancer-causing chemicals in them. The drugmaker followed additional controls, corrective actions, and improvements in place at the facility in question to mitigate the perceived risk of product contamination several months before inspection.

As per FDA, Mylan bought some of its solvents (banned from selling in the U.S.) from an outside company.

The FDA letter recommended Mylan to hire a consultant to improve its manufacturing practices.