In his letter Bliley wrote that the interpreter explained to the inspector that Hua Lian had "copied information from the Roussel NDA [the New Drug Application of Roussel Uclaf, the French company that first developed and manufactured RU486] in a number of sections rather than translate their own methods from Chinese to English." The inspector reported that the interpreter also relayed information that the firm's consultant "told them that FDA wants all raw materials to meet
USP1 specifications so they inserted numerous references to general USP chapters in the CMC which have nothing to do with the testing they perform."