# Cardiocommand Inc. – FDA 483, Jul 30, 2026

Source: https://www.keypedia.com/records/483/cardiocommand-inc/8e837458-b76d-443e-843b-c276cf097457

> FDA 483 for Cardiocommand Inc. on July 30, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardiocommand Inc.
- Inspection Date: 2026-07-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of CardioCommand, Inc. in Tampa, FL, a medical device manufacturer, revealed a significant lack of documented risk management processes for their (b)(4) PMA (b)(4) product. The firm acknowledged the absence of a formal risk management system, leading to a deficiency in required records for identifying and mitigating device hazards. This indicates a serious compliance issue regarding product safety and quality system regulations.

## Related Documents

- [483 - 2022-12-09](https://www.keypedia.com/records/483/cardiocommand-inc/3838d501-cabc-482a-baab-2cec4d050397) — date: December 9, 2022

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/cardiocommand-inc/88de784c-39f6-41c3-91c1-50b662d2f2aa

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6