FDA 483 - VEGANIC SKN LIMITED - July 21, 2025

From July 15 to July 21, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Veganic SKN Limited, a finished product manufacturer located in Rocklea, Queensland, Australia. The inspection identified significant lapses in the company’s adherence to Current Good Manufacturing Practice (CGMP) standards, particularly regarding quality oversight and safety testing.

The primary violations centered on the Quality Control Unit (QCU), which lacked written procedures and independent authority. The investigator found that production personnel were performing quality assurance tasks, creating a conflict of interest that compromised objective oversight. This led to several products being released to the U.S. market without final approval, with unfinished laboratory testing, or despite failed quality results. Furthermore, the company failed to conduct necessary microbiological testing on high-risk formulations and skipped mandatory identity tests for raw materials, relying solely on supplier documentation.

Additional concerns were raised regarding product stability; the firm calculated expiration dates from the time of packaging rather than the time of manufacture, potentially misrepresenting the product’s shelf life. The firm also lacked data to ensure products remained free of contamination during storage phases.

While this document reflects preliminary observations and not a final determination of compliance, Veganic SKN Limited is required to submit a formal response to the FDA. This response must detail the corrective actions the firm has taken or plans to implement to address these safety and quality deficiencies.