5 Homeopathic Drug Companies Warned on CGMPs

FDA says it has sent Warning Letters to five companies that produce products labeled as homeopathic for significant violations of current good manufacturing practice regulations. An agency media release says four of the letters pertain to companies that jointly produced a product labeled as homeopathic that posed a significant risk to consumers because their purportedly sterile products were not shown to be sterile. An additional letter outlined a company’s failure to have systems in place to assure proper design, monitoring, and control of manufacturing processes.

Letters were sent to Kadesh, Inc., U.S. Continental Marketing, Inc., Fill It Pack It, Inc., Bershtel Enterprises LLC, and Newton Laboratories.

The media statement says that earlier this year FDA issued separate Warning Letters to additional companies regarding violative products labeled as homeopathic.