# FDA 483 - GenCure Tissue Center - February 14, 2020

Source: https://www.globalkeysolutions.net/records/483/gencure-tissue-center/40001176-7162-4021-97e4-2fb5c8c6c127

> FDA 483 for GenCure Tissue Center on February 14, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GenCure Tissue Center
- Inspection Date: 2020-02-14
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: GenCure Tissue Center in San Antonio, TX, an HCT/P Recovery Facility, was cited for inadequate investigation and corrective actions regarding environmental monitoring deviations. The firm failed to determine the cause or implement preventative measures for repeated instances of unacceptable Colony Forming Units (CFUs) in cleanroom areas. This indicates a significant lapse in quality control and deviation management.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maira-p-brading/892072f4-e584-48d1-890c-e0a47dfbdffa)
- [Christopher Martin](https://www.globalkeysolutions.net/people/christopher-martin/e77919d2-dbee-42db-9980-910acd4e1ed3)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/gencure-tissue-center/b848d4e2-c810-4230-9d3a-a9701caec113

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