# FDA 483 - BRAINCHECK, INC. - September 18, 2025

Source: https://www.globalkeysolutions.net/records/483/braincheck-inc/ac3239be-843e-439e-ba1d-dbb7588a646a

> FDA 483 for BRAINCHECK, INC. on September 18, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BRAINCHECK, INC.
- Inspection Date: 2025-09-18
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of BRAINCHECK, INC. in Austin, TX, from September 15-18, 2025, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately establish procedures for disseminating information on quality problems and lacked consistent documentation to verify the effectiveness of CAPA actions. These findings indicate a need for improved quality system controls.

## Related Officers

- [Katherine M. Thames](https://www.globalkeysolutions.net/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)

Company: https://www.globalkeysolutions.net/companies/braincheck-inc/b2e8adb4-9c73-4247-9f50-e2f25469fdac

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9