# FDA 483 - Cogmedix, Inc. - April 11, 2024

Source: https://www.globalkeysolutions.net/records/483/cogmedix-inc/81b196d3-6620-4da1-9739-9cc4d51796f3

> FDA 483 for Cogmedix, Inc. on April 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cogmedix, Inc.
- Inspection Date: 2024-04-11
- Product Type: device
- Office Name: New England District Office
- Summary: Cogmedix, Inc. in West Boylston, MA, a medical device establishment, was cited for several quality system deficiencies during an FDA inspection. Observations included failure to report accidental radiation occurrences, inadequate procedures for rework of nonconforming products, and insufficient corrective and preventive action processes. Additionally, the firm's supplier requirements and evaluation methods were found to be inadequately established.

## Related Documents

- [483 - 2022-03-07](https://www.globalkeysolutions.net/records/483/cogmedix-inc/adf49f87-b066-494f-8069-5398b6742a51)

## Related Officers

- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144