According to Zachary Brennan’s article on RAPS, an Indian active pharmaceutical ingredient (API) manufacturer, Megafine, was banned from FDA after a 483 inspection. Other regulators around the world have approved the company; however that may change soon. The notes indicated manipulated lab tests and unjustified difference in test results.
In order for companies to be removed from the unapproved list, they must demonstrate to FDA that the issues have since been resolved. Need help in overseeing your manufacturer CMOs? Contact us.
To read Brennan’s article, click here.