FDA 483 - Qilu Pharmaceutical Co., Ltd. (Dongjia Site) - June 12, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of Qilu Pharmaceutical Co., Ltd.'s sterile API manufacturing facility in Jinan, China, revealed significant deficiencies in aseptic processing and environmental controls. Observations included a lack of air sampling, inadequate disinfection practices, particulate shedding from cleaning cloths, and poor facility organization. Furthermore, the firm failed to conduct thorough investigations into deviations and out-of-specification results, lacking justified root causes and preventative actions.
ID · 545b9a08-bcbc-48af-be2e-2affd5d07e91