# FDA 483 - Sanmina Sci Israel Medical Systems Ltd. - June 16, 2022

Source: https://www.globalkeysolutions.net/records/483/sanmina-sci-israel-medical-systems-ltd/f8d5b0a0-467a-4c81-930c-ef37c001d10d

> FDA 483 for Sanmina Sci Israel Medical Systems Ltd. on June 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanmina Sci Israel Medical Systems Ltd.
- Inspection Date: 2022-06-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Sammina Sci Israel Medical Systems Ltd. in Maalot, Israel, a contract manufacturer, from June 13-16, 2022, identified a significant issue with the firm's process validation documentation. The company failed to adequately document performance qualification activities and manufacturing line validations for the assembly of the QDOT MICRO System Mother Board. This indicates a deficiency in their quality system regarding process control and record-keeping.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/sanmina-sci-israel-medical-systems-ltd/5c985854-17aa-4330-9cf5-b6c7f2343041

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