# FDA 483 - Medcore Biologix LLC - November 19, 2019

Source: https://www.keypedia.com/records/483/medcore-biologix-llc/9c693882-7e11-4793-8648-40b26c303508

> FDA 483 for Medcore Biologix LLC on November 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medcore Biologix LLC
- Inspection Date: 2019-11-19
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/everard-a-irish/840ad8d1-1e8a-4ade-9b3b-64f654754d17)

Company: https://www.keypedia.com/companies/medcore-biologix-llc/e36af2d2-7dbb-4abf-8362-887316c2b139

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