The U.S. Food and Drug Administration (FDA) recently hit a Mylan manufacturing plant in India with a warning letter based on what it sees as a lack of quality control. The findings were based on a September inspection of a facility that produces antiretroviral therapies for HIV.
The letter, dated April 3, alleges that Mylan’s “quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs,” and that its processes do not conform to CGMP.
Violations outlined by the FDA include shoddy data practices that include missing, deleted and lost data as well as failing to investigate unexplained discrepancies in drug batches.
Until the FDA confirms compliance with standard manufacturing practices from Mylan, it may withhold approval of any new applications.