FDA 483 - Hangzhou Facecare Cosmetics Co., Ltd. - April 05, 2019

Hangzhou FaceCare Cosmetics Co. Ltd., an OTC drug manufacturer in Hangzhou, China, was cited for ten observations during an FDA inspection. The observations primarily concern deficiencies in quality control, record-keeping, and validation procedures across various aspects of manufacturing, including material identification, equipment calibration, sampling, cleaning, testing methods, and supplier qualification. These issues indicate a lack of robust control over critical manufacturing processes and documentation.