FDA 483 - Neurotris, Inc. dba A1 Engineering - April 25, 2023

Neurotris, Inc. dba A1 Engineering in Irvine, CA, was inspected by the FDA from April 4-25, 2023. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning design change control, corrective and preventive actions, non-conforming product control, and purchasing procedures for medical devices. These issues indicate a lack of adequate procedures and documentation for critical manufacturing and quality processes.