FDA 483 - UBI Pharma, Inc.

UBI Pharma Inc., a drug product manufacturer in Hsinchu County, Taiwan, was cited for significant deficiencies in its laboratory control system and manufacturing processes. Observations included incomplete raw data records lacking final conclusive results for various tests, as well as the absence of final summary reports for stability and environmental monitoring data. Additionally, executed batch records failed to document and justify deviations in manufacturing parameters, specifically regarding vial capping speeds.