FDA 483 - Applied Neuroscience, Inc. - April 11, 2022

Applied Neuroscience, Inc. in St Petersburg, FL, a manufacturer of medical device software, was inspected by the FDA from April 4-11, 2022. The inspection revealed significant and repeat deficiencies across multiple critical quality system areas, including CAPA, complaint handling, design controls, document control, management review, quality audits, and training. The firm's quality system appears to be largely undeveloped or poorly implemented, indicating a high level of non-compliance.