# FDA 483 - Pace Tech, Inc. - November 15, 2024

Source: https://www.keypedia.com/records/483/pace-tech-inc/566f7669-6030-4419-bfba-77cd199f6cd9

> FDA 483 for Pace Tech, Inc. on November 15, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pace Tech, Inc.
- Inspection Date: 2024-11-15
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Pace Tech, Inc. in Clearwater, FL, a manufacturer of medical devices, revealed significant quality system deficiencies. The firm failed to properly label its VitalMax and MiniPack patient cardiac monitors with Unique Device Identifiers (UDI), did not document acceptance activities in the device history record, and lacked established procedures for corrective and preventive action. These observations indicate a need for comprehensive improvements in the firm's quality management system.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/suzanne-m-healy/a4159f42-8968-4dec-89e3-46a5412bc47a)

Company: https://www.keypedia.com/companies/pace-tech-inc/441377c4-6724-4629-9f98-850ba7d491e5

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