FDA 483 - Shanghai SynTheAll Pharmaceutical Co., Ltd. - November 30, 2018
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.
During an inspection of STA Pharmaceutical Co., Ltd. in Jinshan District, Shanghai, FDA investigators observed a significant quality control issue. A critical study to determine the potential of a starting material used in API manufacture was not completed until after the API had already been manufactured and distributed for Phase clinical trials. The study ultimately concluded the material was a weak substance, indicating a potential risk to product quality and patient safety.
ID · 417c14d3-4e42-45cc-b2e2-a47f5bc81ee7