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

Source: https://www.keypedia.com/records/483/neurodynamics-inc/39bab729-7048-496d-a1dd-62d5bf3cd4c9

> FDA 483 for Neurodynamics, Inc. on July 21, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neurodynamics, Inc.
- Inspection Date: 2021-07-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Documents

- [483 - 2024-02-28](https://www.keypedia.com/records/483/neurodynamics-inc/0403deb9-0a7b-43c3-9bbe-f9f9ac9baed8)

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/neurodynamics-inc/d6d11616-e9b8-47b1-aaca-e2558babb104

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961