483
Neurodynamics, Inc.Neurodynamics, Inc. – FDA 483, Feb 28, 2024
Record Details
Neurodynamics, Inc., a medical device manufacturer in New York, NY, was inspected and cited for failing to maintain written Medical Device Reporting (MDR) procedures. Specifically, the firm lacked an electronic MDR (eMDR) procedure and had not established an Electronic Submissions Gateway (ESG) account to report serious injuries and deaths. This indicates a significant lapse in their post-market surveillance and reporting obligations.
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ID · 0403deb9-0a7b-43c3-9bbe-f9f9ac9baed8
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