# Astura Medical – FDA 483, Apr 23, 2026

Source: https://www.keypedia.com/records/483/astura-medical/3e888934-4160-4017-9cad-af64a926de44

> FDA 483 for Astura Medical on April 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Astura Medical
- Inspection Date: 2026-04-23
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Astura Medical in Irving, TX, a specification developer of Class 2 spinal implants, revealed significant deficiencies across its quality system. Observations included inadequate documentation for design and development changes, insufficient validation of cleaning processes, and a failure to monitor supplier performance. Additionally, the firm's complaint handling procedures were found to be incomplete, and information from the feedback process was not adequately integrated into risk management activities.

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.keypedia.com/companies/astura-medical/6b9f7829-e2c2-418f-8b4a-88d24989f88f

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9