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

Source: https://www.globalkeysolutions.net/records/483/ten23-health-valais-ag/83145e5a-a987-4b0c-b84f-5a2b02733371

> FDA 483 for ten23 health Valais AG on August 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ten23 health Valais AG
- Inspection Date: 2025-08-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

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- [483 - 2024-02-28](https://www.globalkeysolutions.net/records/483/ten23-health-valais-ag/c195eb48-c4e3-453a-ae5a-65a7cb9e397f)

## Related Officers

- [Sudipan Karmakar](https://www.globalkeysolutions.net/people/sudipan-karmakar/3037fa5f-a982-4b25-ad94-df1c9e81c853)
- [Liqun Zhao](https://www.globalkeysolutions.net/people/liqun-zhao/6fdfb753-7788-4351-9b0b-65e06c201bc5)

Company: https://www.globalkeysolutions.net/companies/ten23-health-valais-ag/7d69d8ad-acae-409b-8630-b4bf5911b613

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8