483
ten23 health Valais AGten23 health Valais AG – FDA 483, Feb 28, 2024
Record Details
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.
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ID · c195eb48-c4e3-453a-ae5a-65a7cb9e397f
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