FDA EIR - APN Health LLC - October 10, 2019

An FDA inspection of APN Health LLC, a Waukesha, WI-based medical device manufacturer, was conducted from October 1-10, 2019. The inspection focused on the company's Navik 3D cardiac mapping system, a Class II medical device, under the Quality System Inspection Technique (QSIT) and medical device regulations (21 CFR Part 820). The inspection resulted in two formal observations (Form FDA 483) and nine verbal observations, indicating significant quality system deficiencies.

The main written observations included inadequate design verification procedures and complaint handling processes. For design verification, APN Health LLC failed to consistently follow its "Test Case Creation and Execution" procedure for Navik 3D software version 2.2, with issues such as missing objective evidence, unaddressed failed test cases, and unfulfilled verification plan requirements. Regarding complaint handling, the firm initiated complaint records after software fixes were deployed, improperly combined multiple feedback forms, lacked documented Medical Device Report (MDR) evaluations, and prematurely closed complaints. Additionally, MDR evaluations did not adequately assess the potential for serious injury or death.

Verbal observations addressed further quality system concerns, including improving Corrective and Preventive Action (CAPA) scope, ensuring hazard alignment with complaints, documenting device history record reviews, revising computerized systems and supplier lifecycle procedures to include consultants and MDR/recall responsibilities, enhancing the MDR procedure, increasing internal audit frequency, and retaining all test data. Management committed to correcting all observations and providing a written response for the formal findings within 15 business days.