FDA 483 - ten23 health Valais AG - August 27, 2025

Valais AG, a drug product manufacturer in Visp, Switzerland, was cited for significant deficiencies in its manufacturing processes. The inspection revealed failures in establishing robust production controls, ensuring sterility through adequate visual inspection and aseptic procedures, and maintaining proper component testing and environmental sanitization programs. These issues collectively indicate a lack of assurance regarding the quality, purity, and sterility of their drug products.