# FDA 483 - Nuline Sensors LLC - April 25, 2023

Source: https://www.keypedia.com/records/483/nuline-sensors-llc/27d8de64-4735-4e00-838a-8639d544a1e2

> FDA 483 for Nuline Sensors LLC on April 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nuline Sensors LLC
- Inspection Date: 2023-04-25
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Nuline Sensors LLC, a medical device manufacturer in Sanford, FL, was inspected by the FDA and received a Form 483 with five observations. The inspection revealed significant issues across multiple quality system areas, including inadequate control of production processes, lack of equipment maintenance schedules, deficiencies in CAPA implementation, and missing Medical Device Reportable (MDR) procedures. These findings indicate a moderate level of non-compliance with quality system regulations.

## Related Documents

- [483 - 2016-01-29](https://www.keypedia.com/records/483/nuline-sensors-llc/9b5b2a00-6bca-4e7b-947a-af66343e1811)

## Related Officers

- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

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

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