FDA 483 - Nuline Sensors LLC - January 29, 2016

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.