FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - June 12, 2026

An FDA inspection of Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) in Jinan, China, revealed significant deficiencies in their drug manufacturing operations. Observations included inadequate qualification of critical manufacturing equipment, failure to establish and follow proper production and process controls, and insufficient laboratory controls for reference standards. These issues indicate a lack of assurance regarding the identity, strength, quality, and purity of drug products.