FDA 483 - UBI Pharma, Inc. - October 14, 2025

UBI Pharma Inc. was cited for significant deficiencies in its manufacturing and quality control processes for sterile injectable drug products. Issues include unqualified visual inspection equipment, inadequate control procedures for particulate matter, failures in aseptic processing, and a dysfunctional quality control unit that neglected complaint investigations and change control. These lapses resulted in the release of potentially compromised drug products to the US market.