Cerno Pharmaceuticals Hit With Warning Letter Over Adulterated Products
The FDA slammed Cerno Pharmaceuticals for producing adulterated drugs at its Miami, Florida facility.
During a November 2017 inspection, the agency’s investigator found that the firm’s product, Verruguin wart remover, was manufactured using a salicylic acid before the component was tested and released for use by the quality unit.
In its response to the inspection observations, the firm said it would create a deviation report for using raw material before final release and train its staff in deviation reporting. But the agency said this was inadequate, noting that manufacturing drugs with untested components violates good manufacturing practices.