FDA 483 - Hanbul Cosmetics Co., Ltd - December 01, 2017

It's Hanbul Co., Ltd. in Eumseong-gun, Chungcheongbuk-do, Korea, an OTC drug manufacturer, was inspected by the FDA from 11/27/17 to 12/01/17. The inspection revealed significant deficiencies across multiple areas of good manufacturing practices, including incomplete batch records, inadequate cleaning validation, lack of microbiological testing data, absent stability programs, and poor control over computer systems and equipment calibration. These findings indicate a broad lack of adherence to regulatory requirements for drug product quality and control.