Qilu Antibiotics Pharmaceutical Co. , Ltd. – FDA 483, Jul 16, 2026
Qilu Antibiotics Pharmaceutical Co.,Ltd. in Jinan, Shandong, a sterile API and drug manufacturer, received a Form 483 with five significant observations. The inspection revealed critical deficiencies in aseptic processing validation, including inadequate airflow studies and media fill programs, and a failure to thoroughly investigate microbiological recoveries and product complaints. Additionally, the firm's visual inspection methods were not adequately qualified, and environmental monitoring procedures for sterile areas were found to be deficient, with some being repeat observations.
ID · 857a6ad7-5d8b-4958-b8b3-cfa3ae2251c9
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