# FDA 483 - NeuroLogica Corporation - January 14, 2020

Source: https://www.keypedia.com/records/483/neurologica-corporation/a61638b5-c9ed-4573-8214-c26f79f4a01b

> FDA 483 for NeuroLogica Corporation on January 14, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroLogica Corporation
- Inspection Date: 2020-01-14
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: NeuroLogica Corporation in Danvers, MA, was cited for three observations related to regulatory reporting and record-keeping for lasers used in their CT Systems. The inspection revealed failures to submit required product reports and annual reports, as well as a lack of adequate test records for electronic product radiation safety. These issues indicate deficiencies in compliance with regulations concerning medical device reporting and safety documentation.

## Related Documents

- [483 - 2024-08-27](https://www.keypedia.com/records/483/neurologica-corporation/99241e3d-3d6b-4b83-9544-3b792848fb2d)

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)
- [Emir Galevi](https://www.keypedia.com/people/emir-galevi/d99d0e13-df64-44a8-af6e-ef28ff50b5b9)

Company: https://www.keypedia.com/companies/neurologica-corporation/112b8be4-8d99-4b9b-b6f8-0335d0ba9af0

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94