# FDA 483 - Footprint Medical, Inc. - March 26, 2026

Source: https://www.keypedia.com/records/483/footprint-medical-inc/4877b9ac-cff0-4952-b787-24a16fd23f2f

> FDA 483 for Footprint Medical, Inc. on March 26, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Footprint Medical, Inc.
- Inspection Date: 2026-03-26
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Footprint Medical, Inc. in San Antonio, TX, from March 23-26, 2026, revealed a significant deficiency in their quality system. The firm failed to establish written quality agreements for outsourced processes that affect the conformity of their Class II Peripherally Inserted Central Catheters (PICC) to requirements. This indicates a lack of adequate control over critical suppliers for components like tubing, steel rods, and sterile pouches.

## Related Documents

- [483 - 2018-09-21](https://www.keypedia.com/records/483/footprint-medical-inc/0b782740-0271-4f01-90d5-464b511004a3)
- [483 - 2018-09-21](https://www.keypedia.com/records/483/footprint-medical-inc/c38d9c4f-2e16-4503-9da2-247edd6cef61)
- [483 - 2023-06-14](https://www.keypedia.com/records/483/footprint-medical-inc/4628155f-390f-493c-a5ae-df8e53d5c3e6)

## Related Officers

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

Company: https://www.keypedia.com/companies/footprint-medical-inc/00df874b-1d79-45b6-a9b9-d3930cddfad0

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