FDA 483 - TTY Biopharm Company Limited Lioudu Factory - August 30, 2022

TTY Biopharm Company Limited Lioudu Factory, an injectable drug manufacturer in Keelung City, Taiwan, was cited for four observations during an FDA inspection. Key issues include inadequate retention of reserve drug product samples, unrecorded deviations from test procedures, insufficient CGMP training for employees, and a lack of hot water in washing and toilet facilities. These observations indicate deficiencies in quality control, documentation, personnel training, and facility maintenance.