FDA EIR - Edwards Lifesciences, LLC - June 14, 2019

An FDA "For Cause" inspection was conducted at Edwards Lifesciences, LLC in Irvine, CA, from May 28 to June 14, 2019. This inspection, conducted under C.P. 7382.845, followed four product recalls initiated by the company since December 2018, involving various cardiovascular medical devices like annuloplasty rings, catheters, and hemodynamic monitoring systems.

The inspection identified three main objectionable conditions, detailed in an FDA Form 483, Inspectional Observations. Firstly, procedures for corrective and preventive actions were not adequately established, notably failing to verify the effectiveness of prior corrective actions for liquid ingress issues causing power supply fires in EV1000 Clinical Platforms. Secondly, process control procedures lacked sufficient detail to ensure product conformance to specifications. Thirdly, procedures for receiving, reviewing, and evaluating customer complaints by a designated unit were not established, contributing to unescalated reports of device malfunctions.

Further discussions highlighted additional concerns: the EV1000 Clinical Platform's operator manual required clearer safety warnings for power supply mounting, risk analysis records for Swan-Ganz catheters contained conflicting information, and balloon inspection procedures needed clarification to prevent overwriting valid test results.

Dr. John P. McGrath, Corporate Vice President, Quality, Regulatory & Clinical, acknowledged the observations, committed to correcting all issues, and promised a written response to the FDA within 15 business days. The FDA also warned of potential sanctions for non-compliance.