# FDA 483 - NeuroLogica Corporation - August 27, 2024

Source: https://www.keypedia.com/records/483/neurologica-corporation/99241e3d-3d6b-4b83-9544-3b792848fb2d

> FDA 483 for NeuroLogica Corporation on August 27, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroLogica Corporation
- Inspection Date: 2024-08-27
- Product Type: device
- Office Name: New England District Office
- Summary: NeuroLogica Corporation, a manufacturer of CT systems in Danvers, MA, was cited for two significant issues during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within 30 days for malfunctions in their CT systems that led to patients needing rescans and additional radiation exposure. Additionally, it was noted as a repeat observation that the firm did not submit required reports for the IEC Class 1M laser incorporated into their CT systems.

## Related Documents

- [483 - 2020-01-14](https://www.keypedia.com/records/483/neurologica-corporation/a61638b5-c9ed-4573-8214-c26f79f4a01b)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

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

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