# FDA 483 - EMSI - December 08, 2022

Source: https://www.globalkeysolutions.net/records/483/emsi/8e0dac7f-ce16-45fe-991b-c65db08509c4

> FDA 483 for EMSI on December 08, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EMSI
- Inspection Date: 2022-12-08
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: EMSI, a Spec Developer in Tampa, FL, was inspected by the FDA from December 5-8, 2022. The inspection revealed deficiencies in the firm's quality system, specifically regarding finished device acceptance procedures and employee training. These issues indicate a lack of adherence to established protocols for device manufacturing and personnel competency.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.globalkeysolutions.net/companies/emsi/e0ee00bc-1ff0-4c20-997f-2001d9280480

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