FDA 483 - Neurodynamics, Inc. - July 21, 2021

An FDA inspection of Neurodynamics, Inc., a medical device manufacturer in New York, NY, revealed a significant compliance issue regarding Medical Device Reporting (MDR) procedures. The firm failed to maintain written MDR procedures, specifically lacking an electronic Medical Device Reporting (eMDR) procedure and an Electronic Submissions Gateway (ESG) account. This deficiency impacts the firm's ability to report serious injuries and death incidents, indicating a serious lapse in regulatory compliance.