Natco India plant gets Form 483 from FDA

Indian drugmaker Natco has joined a long list of compatriots facing FDA concerns over manufacturing issues. According to The Financial Express, the company received an FDA Form 483 for a finished dosage plant in Telangana after an inspection in May. It said the 6 observations had to do with lack of control processes, including procedures to make sure drugs hit the "strength, quality and purity they purport or are represented to have." Plants operated by other large Indian drugmakers like Ranbaxy Laboratories, Wockhardt and Sun Pharmaceuticals, as well as the Canadian drug maker Apotex have not only gotten Form 483's, but also warning letters and had plants banned from exporting to the U.S. until manufacturing problems are resolved. Story | More