# FDA 483 - Medi-Source Partners, LLC - July 25, 2019

Source: https://www.keypedia.com/records/483/medi-source-partners-llc/4c0d8558-7463-4773-825b-86b41b76c4ff

> FDA 483 for Medi-Source Partners, LLC on July 25, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medi-Source Partners, LLC
- Inspection Date: 2019-07-25
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Medi-Source Partners, LLC, an HCT/Ps storage and distribution firm in Dallas, TX, was cited for significant deficiencies during an FDA inspection. The firm lacked established procedures for core CGTP requirements, failed to record and maintain HCT/P storage temperatures, and did not track tissue products. Additionally, procedures for handling complaints were absent, and adopted SOPs were not verified for appropriateness, indicating a systemic failure in maintaining compliant operations.

## Related Officers

- [Compliance Officer at FDA](https://www.keypedia.com/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)

Company: https://www.keypedia.com/companies/medi-source-partners-llc/6706c425-a777-470e-817e-4e3b17cc0023

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