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Sunstar Americas, Inc. was cited for significant violations of Current Good Manufacturing Practice (CGMP) regulations and Quality System (QS) regulations during a January-February 2021 inspection of its Schaumburg, Illinois facility, which manufactures both pharmaceutical drugs and medical devices including GUM HYDRAL OTC products intended to treat dry mouth. The company's manufacturing methods, facilities, and controls were found to be inadequate, resulting in adulterated drug and device products that did not conform to regulatory standards. The FDA determined that the company's March 2021 response to the inspection findings was insufficient and did not provide adequate evidence of corrective actions necessary to achieve compliance.