FDA 483 - Sunnex, LLC - July 03, 2019

An FDA inspection of Sunnex, LLC, a medical device manufacturer in Charlotte, NC, revealed numerous significant deficiencies in its quality system. The firm failed to adequately establish and follow procedures for design validation, design verification, process validation, complaint handling, and documentation. These issues indicate a broad lack of adherence to medical device regulations, impacting the quality and safety of their medical lights.