Neuralink Corporation – FDA 483, Jun 22, 2023

An FDA inspection of Neuralink Corporation, a nonclinical laboratory in Fremont, CA, revealed significant deficiencies in record-keeping and quality assurance practices. The firm failed to maintain adequate documentation for equipment maintenance and calibration, impacting multiple studies and instruments. Additionally, final study reports lacked required Quality Assurance Unit statements, and the QAU did not properly document deviations from approved protocols, including water quality testing.