FDA 483 - Bora Pharmaceuticals Injectables Inc - April 16, 2021

Cangene BioPharma LLC, a pharmaceutical manufacturer in Baltimore, MD, was cited for four observations during an FDA inspection. The findings include failures in thoroughly reviewing batch failures, rejecting non-conforming components, maintaining aseptic technique during sterile drug product manufacturing, and keeping adequate equipment logs. These issues indicate significant concerns regarding quality control and sterile processing practices.