FDA 483 - Qilu Pharmaceutical (Hainan) Co. Ltd. - August 22, 2025

An FDA inspection of Qilu Pharmaceutical (Hainan) Co., Ltd. in Haikou, China, revealed significant deficiencies in their finished drug product manufacturing. Observations included a lack of validated control procedures for manufacturing processes, undersized equipment leading to operational errors, and the use of laboratory instruments that did not meet established specifications, specifically dissolution testers with asymmetrical basket rotation. These issues indicate potential risks to product quality and consistency.