# FDA 483 - Tegra Medical Costa Rica Sa - June 29, 2023

Source: https://www.keypedia.com/records/483/tegra-medical-costa-rica-sa/f5c9d02e-4df4-48bf-8428-7e657c7633f0

> FDA 483 for Tegra Medical Costa Rica Sa on June 29, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tegra Medical Costa Rica Sa
- Inspection Date: 2023-06-29
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The FDA inspected Tegra Medical Costa Rica Sa, a contract manufacturer, from June 26-29, 2023. The inspection revealed that the firm's corrective and preventive action (CAPA) procedures were not adequately established. Specifically, the CAPA procedure failed to properly identify or reference the severity classification matrix used for assigning risk due dates.

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## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/tegra-medical-costa-rica-sa/55c32ada-e400-4f64-a497-006854c2b74c

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