FDA 483 - Qilu Pharmaceutical (Hainan) Co. Ltd. - May 11, 2023

Qilu Pharmaceutical (Hainan) Co., Ltd. in Haikou, Hainan, was cited for significant deficiencies across its manufacturing operations. The inspection revealed issues with environmental controls, aseptic processing, laboratory controls for product specifications and sterility testing, and complaint handling procedures. These observations indicate a lack of assurance in the sterility, quality, and purity of drug products, as well as inadequate adverse event reporting.