# FDA 483 - Nuline Sensors LLC - January 29, 2016

Source: https://www.globalkeysolutions.net/records/483/nuline-sensors-llc/9b5b2a00-6bca-4e7b-947a-af66343e1811

> FDA 483 for Nuline Sensors LLC on January 29, 2016. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nuline Sensors LLC
- Inspection Date: 2016-01-29
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Nuline Sensors LLC, a medical device specification developer in Sanford, FL, was cited for multiple quality system deficiencies during an FDA inspection. The observations primarily focused on inadequate design controls, including issues with design history files, risk analysis, and input documentation. Additional concerns were raised regarding insufficient procedures for purchasing controls, complaint handling, corrective and preventive actions, and medical device reporting.

## Related Documents

- [483 - 2023-04-25](https://www.globalkeysolutions.net/records/483/nuline-sensors-llc/27d8de64-4735-4e00-838a-8639d544a1e2)

## Related Officers

- [Principal ](https://www.globalkeysolutions.net/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.globalkeysolutions.net/companies/nuline-sensors-llc/f83ef549-e54a-4ae7-8363-af0bb1442d65

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