# FDA 483 - Miami Device Solutions, LLC. - September 16, 2021

Source: https://www.keypedia.com/records/483/miami-device-solutions-llc/fa68aab0-4f54-4f6d-ba39-46570f72807d

> FDA 483 for Miami Device Solutions, LLC. on September 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Miami Device Solutions, LLC.
- Inspection Date: 2021-09-16
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Miami Device Solutions, LLC in Miami, FL was inspected from September 13-16, 2021, and received a Form FDA 483. The inspection revealed significant deficiencies in the documentation of corrective and preventive action (CAPA) activities. Specifically, CAPA investigations lacked documented evidence for all activities, including proposed corrective actions, their implementation, evaluations, and training for procedural updates, as well as results for design verification and defined effectiveness verification.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)

Company: https://www.keypedia.com/companies/miami-device-solutions-llc/9a61cda8-ed44-4317-9d5c-a2fae34eb83a

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