# FDA 483 - ten23 health Valais AG - April 24, 2019

Source: https://www.globalkeysolutions.net/records/483/ten23-health-valais-ag/63581208-7264-4919-ade7-fd1f2306a687

> FDA 483 for ten23 health Valais AG on April 24, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ten23 health Valais AG
- Inspection Date: 2019-04-24
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Swissfillon AG, a contract drug manufacturer in Visp, Switzerland, was cited for significant deficiencies in its aseptic processing areas. The inspection revealed inadequate environmental monitoring procedures, leading to microbial growth exceeding acceptance criteria, and a lack of proper cleaning and gowning instructions, resulting in observed improper aseptic techniques and potential product contamination.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)
- [Jamie L. C. Dion](https://www.globalkeysolutions.net/people/jamie-l-c-dion/bea1370f-d56e-4eb1-8026-fcdec73d6eae)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1