FDA 483 - NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT - July 03, 2024

During an FDA inspection conducted from July 1-3, 2024, NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, operating as NEUFIT, received a Form FDA 483 detailing significant observations regarding its complaint handling processes. The company, classified as a Repackager/Relabeler/Complaint File Establishment, was found to have two primary issues. Firstly, the firm did not promptly review, evaluate, or investigate complaints that appeared to be reportable as Medical Device Reports (MDRs) by a designated individual. Specifically, records for complaints involving serious adverse events, such as one where untrained personnel used a device resulting in injury and another concerning Rhabdomyolysis, lacked required signatures and dates from a qualified medical professional, indicating a failure to adhere to their own procedures for determining reportability. Secondly, NEUFIT's procedures for receiving, reviewing, and evaluating complaints were deemed inadequate. The inspection revealed deficiencies in documenting oral complaints, consistently evaluating all complaints for MDR reportability, and ensuring that essential information, including complainant details, was fully recorded. Furthermore, complaint investigations often lacked thoroughness, failing to include documented investigative steps like functional testing or product traceability information for devices involved in adverse events, such as a patient experiencing "immense pain" or a dislocated kneecap. These observations highlight non-conformance with essential quality system requirements for medical device establishments. NEUFIT has committed to correcting these deficiencies.