FDA 483 - VEGANIC SKN LIMITED - July 21, 2025

The FDA inspected Veganic SKN Limited, a finished product manufacturer in Rocklea, Australia, from July 15-21, 2025. The inspection revealed significant deficiencies in quality control unit procedures, authority, and oversight, including the release of drug products without proper QA approval, with open OOS investigations, and without complete test results. Additionally, the firm failed to conduct required microbiological and component identification testing, and assigned expiration dates without adequate stability data or hold time studies, indicating a systemic lack of robust quality assurance practices.