# FDA 483 - Medistri SA - May 09, 2024

Source: https://www.globalkeysolutions.net/records/483/medistri-sa/8870fee7-0109-4a4c-889c-039a1b908477

> FDA 483 for Medistri SA on May 09, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medistri SA
- Inspection Date: 2024-05-09
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Medistri SA, a contract sterilizer, was cited with two observations during an FDA inspection in Domdidier, Switzerland. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established, lacking complete documentation for effectiveness verification and risk assessments. Additionally, the company's complaint handling process was deemed insufficient, failing to ensure proper identification and uniform processing of customer complaints.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.globalkeysolutions.net/companies/medistri-sa/8cfed4a9-8805-433d-a1c0-14bed6d7f7f1

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd