FDA 483 - Bora Pharmaceuticals Injectables Inc - February 18, 2022

Cangene BioPharma LLC in Baltimore, MD, a drug product manufacturer, was cited for multiple deficiencies during an FDA inspection. Issues included inadequate recertification of HEPA filters in aseptic processing areas, a significant backlog of overdue deviations without proper extensions or severity classifications, and insufficient procedures for maintaining equipment and documenting disinfectant contact times. Additionally, the firm failed to follow proper aseptic techniques and lacked an adequate rejection rate for visually inspected incoming glass vials.