# FDA 483 - Mpi Medical Products, Inc. - December 04, 2018

Source: https://www.keypedia.com/records/483/mpi-medical-products-inc/4f5cdc91-975e-4a0d-8815-3779504bc749

> FDA 483 for Mpi Medical Products, Inc. on December 04, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Mpi Medical Products, Inc.
- Inspection Date: 2018-12-04
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: This FDA Form 483 report details significant deficiencies at MPI Medical Products, Inc. in Palm Bay, FL, a medical device manufacturer. The inspection revealed multiple issues with the firm's quality system procedures, including inadequately established procedures for design changes, corrective and preventive actions, quality audits, supplier control, medical device reporting, and device history records. Several of these deficiencies were noted as repeated from previous inspections, indicating a persistent lack of compliance.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/mpi-medical-products-inc/f33b05f2-7a2c-4764-bca5-83ce01cb8fc0

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