FDA 483 - NEURELEC - June 02, 2022

During an FDA inspection conducted from May 30 to June 2, 2022, Oticon Medical, a medical device manufacturer located in Vallauris, France, was cited for two significant observations documented in an FDA Form 483. The inspection highlighted deficiencies in the company's quality system, specifically pertaining to complaint handling and corrective and preventive actions.Observation 1 noted that procedures for receiving, reviewing, and evaluating complaints were inadequate. The firm's complaint management procedures did not ensure uniform and timely processing, documentation upon receipt, or proper evaluation for Medical Device Report (MDR) reportability. Examples included complaints not registered immediately, delays up to two weeks, and insufficient documentation of MDR evaluations and investigation timelines.Observation 2 identified inadequate documentation of corrective and preventive action (CAPA) activities. A specific instance involved a recall related to Cochlear Implant device hermeticity failures. The investigation into these failures lacked essential documentation regarding methods, results, participating personnel, investigation dates, and the rationale for determining affected units.These observations indicate non-compliance with the regulatory framework governing medical device quality systems. Oticon Medical has acknowledged these findings and committed to implementing corrective actions to address both noted deficiencies.