# FDA 483 - Cogmedix, Inc. - March 07, 2022

Source: https://www.globalkeysolutions.net/records/483/cogmedix-inc/adf49f87-b066-494f-8069-5398b6742a51

> FDA 483 for Cogmedix, Inc. on March 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cogmedix, Inc.
- Inspection Date: 2022-03-07
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Cogmedix, Inc. in West Boylston, MA was inspected from March 2-7, 2022, revealing a significant concern regarding quality control. The firm failed to adequately investigate and evaluate the potential adverse effects on medical device quality when test and measurement equipment was found to be malfunctioning or not meeting specified accuracy and precision limits. This indicates a lapse in ensuring device quality and safety.

## Related Documents

- [483 - 2024-04-11](https://www.globalkeysolutions.net/records/483/cogmedix-inc/81b196d3-6620-4da1-9739-9cc4d51796f3)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.globalkeysolutions.net/companies/cogmedix-inc/d94764f2-2a76-4c03-bdeb-ed135912fe6c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7