# FDA 483 - Footprint Medical, Inc. - September 21, 2018

Source: https://www.keypedia.com/records/483/footprint-medical-inc/c38d9c4f-2e16-4503-9da2-247edd6cef61

> FDA 483 for Footprint Medical, Inc. on September 21, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Footprint Medical, Inc.
- Inspection Date: 2018-09-21
- Product Type: device
- Office Name: Denver District Office
- Summary: Footprint Medical, Inc. in San Antonio, TX, a medical device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed inadequate process validation for its PIIC catheters, insufficient risk analysis, and a lack of a standardized review process for Medical Device Reporting. Additionally, production processes were not adequately developed to ensure device conformity to specifications.

## Related Documents

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

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

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

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face