FDA warns homeopathic product makers of CGMP violations
July 1, 2019FDA News Release (05/14/19)
FDA said Tuesday it has issued warning letters to five companies that product homeopathic products for significant violations of current good manufacturing practice (CGMP) regulations. According to the agency, four of the letters relate to companies that jointly produced a product labeled as homeopathic that posed a significant safety risk to consumers because their allegedly sterile products were not found to be sterile. The fifth letter details a company's failure to have systems in place to ensure the proper design, monitoring, and control of manufacturing processes. "It's our public health obligation to protect consumers from unsafe products. Our manufacturing requirements are designed to ensure the quality and safety of drugs distributed to American consumers, and the FDA expects companies to manufacture and label their products appropriately," said FDA Acting Commissioner Ned Sharpless, MD. "When products labeled as homeopathic are contaminated or contain potentially harmful ingredients, we will take action so consumers are not put at risk." The letters issued to Kadesh Inc., U.S. Continental Marketing, Fill It Pack It, and Bershtel Enterprises, dba as WePackItAll, detail failures to conform to CGMP requirements due to improper methods, facilities, or controls for manufacturing, processing, and packing. The companies jointly manufacture and package Puriton Eye Relief Drops. A warning letter was also issued to Newton Laboratories for human drug CGMP and misbranding violations and unapproved new animal drug violations.