Skip to Main Content

The Food and Drug Administration has found “significant violations” of manufacturing regulations at a Mylan Pharmaceuticals facility in India that makes HIV drugs, according to a warning letter to the company.

An inspection in September found that Mylan “failed to establish an adequate quality control unit” that could make sure no errors had occurred during production and that any errors that did occur would be investigated, the letter says. As a result, error signals that indicated the loss of certain data were not being investigated until after the FDA inspection at the plant, located in the city of Nashik.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED