FDA 483 - Qilu Pharmaceutical (Hainan) Co. Ltd. - November 06, 2019

An FDA inspection of Qilu Pharmaceutical (Hainan) Co., Ltd., a sterile drug manufacturer, revealed multiple significant deficiencies. These included failures in following written procedures for visual inspection of in-process materials, inadequate investigations into unexplained discrepancies, and a lack of established or followed procedures to prevent microbiological contamination. Additionally, the firm failed to thoroughly review unexplained discrepancies and ensure the accuracy of computer system input and output, particularly concerning audit trails for filter integrity testing instruments.