FDA 483 - Applied Neuroscience, Inc. - March 03, 2026

An FDA inspection of Applied Neuroscience, Inc., a medical device manufacturer in St Petersburg, FL, revealed significant deficiencies in its quality management system. Observations included inadequate document control, failure to perform design and development validation, lack of internal audits, and undocumented processes for establishing employee competence. These issues highlight a systemic problem with documentation and adherence to established procedures.