FDA 483 - Mayne Pharma International PTY LTD - October 18, 2019

An FDA inspection of Mayne Pharma International PTY LTD in Salisbury South, Australia, revealed deficiencies in the supervision of drug product manufacturing. Specifically, individuals responsible for overseeing production lacked the necessary experience, leading to improper gowning practices during a training session where exposed hair was observed in a manufacturing area. This lapse raises concerns about the assurance of drug product safety, identity, strength, quality, and purity.