FDA 483 - ten23 health Valais AG - February 28, 2024

The FDA inspected ten23 health Valais AG, a drug product manufacturer in Visp, Switzerland, and found significant deficiencies in aseptic processing, environmental monitoring, quality control, and CAPA effectiveness. Observations included inadequate procedures to prevent microbiological contamination, persistent mold issues in cleanrooms, and insufficient visual inspection qualification for drug products. These issues indicate a high risk of product contamination and quality control failures.