# FDA 483 - Biometrix Ltd. - August 15, 2019

Source: https://www.keypedia.com/records/483/biometrix-ltd/e1276bbb-125f-474c-97ab-e96ba62c0b3a

> FDA 483 for Biometrix Ltd. on August 15, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biometrix Ltd.
- Inspection Date: 2019-08-15
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Biometrix Ltd. in Jerusalem, Israel, a contract manufacturer, revealed significant deficiencies in its design control procedures. The firm failed to adequately establish procedures for design changes and design transfer, and did not properly document design review results for its medical devices, including the Thorametrix Dry device. These issues indicate a lack of robust quality system practices for medical device development.

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.keypedia.com/companies/biometrix-ltd/afe52d30-ea1b-4384-83f4-ae6ddf28e722

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