FDA 483 - Medcore Biologix LLC - November 19, 2019

Medcore Biologix LLC, an HCT/P storage and distributor in San Antonio, TX, was cited for significant deficiencies in its Current Good Tissue Practice (CGTP) compliance. The inspection revealed a lack of established written procedures for critical operations such as tissue receipt, storage, packaging, distribution, and disposition. Furthermore, the firm failed to conduct periodic quality audits and lacked procedures for handling complaints related to CGTP requirements.