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

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.