# FDA 483 - MindSight Medical LLC - May 05, 2025

Source: https://www.globalkeysolutions.net/records/483/mindsight-medical-llc/7716aaa7-4631-4ed6-a7df-f0d8bd3f22e8

> FDA 483 for MindSight Medical LLC on May 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MindSight Medical LLC
- Inspection Date: 2025-05-05
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: MindSight Medical LLC in Dallas, TX, a human tissue distributor, was cited for two observations during an FDA inspection. The firm failed to establish acceptable temperature limits for storing HCT/Ps according to manufacturer specifications and lacked defined temperature ranges for frozen HCT/Ps. Additionally, the firm's Standard Operating Procedures did not define corrective actions for temperature excursions during HCT/P storage.

## Related Documents

- [483 - 2019-02-22](https://www.globalkeysolutions.net/records/483/mindsight-medical-llc/48022a9e-5ac6-4862-a831-9f7c1cfec096)

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

Company: https://www.globalkeysolutions.net/companies/mindsight-medical-llc/001b8295-3db8-460f-8f56-d13532a32b53

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