FDA 483 - Apothecus Pharmaceutical Corp. - May 17, 2021

Apothecus Pharmaceutical Corp. received a Form 483 citing significant deficiencies across multiple areas, including inadequate computer system controls, failure to follow quality unit responsibilities, and insufficient laboratory controls. Repeated observations from a previous inspection highlight persistent issues with data integrity, analytical method validation, and OOS investigations. The firm also demonstrated a lack of employee training, unvalidated process changes, unjustified deviation closures, and poor facility maintenance.