FDA 483 - Nuline Sensors LLC - April 25, 2023

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.