FDA 483 - AMO (Hangzhou) Co., Ltd. - July 02, 2019

An FDA inspection of AMO (Hangzhou) Co., Ltd., a sterile OTC drug manufacturer, revealed significant deficiencies. Observations included inadequate controls over computer systems leading to deleted data and shared administrator passwords, as well as insufficient validation of aseptic processes. Additionally, the quality control unit's procedures for aseptic interventions and environmental controls were found to be lacking or not fully followed.