FDA 483 - Pinnacle Labs of Tennessee, LLC - November 03, 2023

An FDA inspection of Pinnacle Labs of Tennessee, LLC in Nashville, TN, a specification developer, revealed significant deficiencies in their quality system. The firm failed to establish procedures for complaint handling and medical device reporting (MDR). Additionally, issues were noted with Unique Device Identifier (UDI) requirements for their Pinnacle BioLabs Second Generation FIT tests, including lack of UDI on packaging and incomplete GUDID registration.