# FDA 483 - Valtronic Technologies SA - April 06, 2023

Source: https://www.globalkeysolutions.net/records/483/valtronic-technologies-sa/8b120352-ce8c-49c6-a695-5fb80ff9ec1b

> FDA 483 for Valtronic Technologies SA on April 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Valtronic Technologies SA
- Inspection Date: 2023-04-06
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Valtronic Technologies SA, a contract manufacturer in Les Charbonnieres, Switzerland, revealed significant deficiencies in their quality system. The firm was cited for failing to establish procedures for product acceptance and for not adhering to their own document control procedures. These issues indicate a lack of robust quality management practices for medical device manufacturing.

## Related Officers

- [Sargum C. Morgan](https://www.globalkeysolutions.net/people/sargum-c-morgan/a769e36a-3382-414a-b9b1-1ebc755c8392)

Company: https://www.globalkeysolutions.net/companies/valtronic-technologies-sa/6b2533f2-e6ad-4d8e-9617-4b0847f9416a

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