FDA 483 - Bloomage Biotechnology Corp., Ltd. - April 26, 2019

An FDA inspection of Bloomage Biotechnology Corp., LTD., an API manufacturer in Jinan, China, revealed significant deficiencies in their quality control systems. Observations included failures in quality unit responsibilities regarding chromatographic data review, inadequate analytical method validation, and incomplete laboratory instrument calibration records. Additionally, the firm did not conduct appropriate laboratory tests for raw materials, intermediates, and APIs.