# BRAINSPEC, INC – FDA 483, Jun 24, 2026

Source: https://www.keypedia.com/records/483/brainspec-inc/a799859a-f455-4ffd-aaff-5a5202ba9263

> FDA 483 for BRAINSPEC, INC on June 24, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BRAINSPEC, INC
- Inspection Date: 2026-06-24
- Product Type: other
- Office Name: New England District Office
- Summary: An FDA inspection of BRAINSPEC, INC in Framingham, MA, revealed significant deficiencies in their preventive action procedures related to the BrainSpec Core™ Software. The firm failed to establish and implement proper procedures, including ensuring they were approved before use and verifying the effectiveness of implemented actions. These findings indicate a lack of robust quality system controls.

## Related Officers

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

Company: https://www.keypedia.com/companies/brainspec-inc/70a43445-2c00-4810-8285-33578beac3a2

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