Taiwanese Manufacturer Cited for Multiple Violations

The FDA flagged UBI Pharma for a slew of violations at its Hsinchu County, Taiwan, facility including inadequate environmental monitoring and sterility practices.

During its inspection, the agency found that the firm’s environmental monitoring procedures for aseptic filling of certain injectable drug products intended for U.S. marketing were inadequate. Among the reasons: the procedures didn’t fully assess the microbiological conditions in the filling room and equipment, failing to include several sampling locations.

For example, dynamic air samples were not collected in the empty vial conveyor area after the vials exited a machine, and dynamic air samples were not collected in the stopper bowl area, where operators engaged in constant loading of stoppers during aseptic filling.