# FDA 483 - Nagl MedTech - September 20, 2022

Source: https://www.keypedia.com/records/483/nagl-medtech/5ab9ff74-4c49-48fd-ad53-3292492467df

> FDA 483 for Nagl MedTech on September 20, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nagl MedTech
- Inspection Date: 2022-09-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Naglreiter Consulting, LLC, a contract manufacturer in Miramar, FL, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate supplier controls, unvalidated manufacturing processes, and failures in design validation and risk analysis documentation. The firm also failed to adequately establish procedures for device history records.

## Related Officers

- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

Company: https://www.keypedia.com/companies/nagl-medtech/750f7e5a-7519-4180-ac21-cd1681123b7e

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