# FDA 483 - Specialty Blood Center - April 29, 2022

Source: https://www.keypedia.com/records/483/specialty-blood-center/5a16548b-ae3b-4939-a02f-401cc3b01f14

> FDA 483 for Specialty Blood Center on April 29, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Blood Center
- Inspection Date: 2022-04-29
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Vitrologic, Inc., dba Specialty Blood Center, a blood establishment in Charleston, SC, was cited for multiple deficiencies during an FDA inspection. The observations primarily concern failures in donor screening, testing, notification of reactive results, and maintaining current standard operating procedures, indicating significant issues in ensuring the safety and quality of collected blood and blood components.

## Related Documents

- [483 - 2018-06-21](https://www.keypedia.com/records/483/specialty-blood-center/4ec05d89-71d0-4bda-a8e3-52727dedfe27)
- [483 - 2019-12-16](https://www.keypedia.com/records/483/specialty-blood-center/f8a13820-2ed8-4b05-b421-dd0266afcb26)

## Related Officers

- [investigator](https://www.keypedia.com/people/leslie-w-gilbert/5c8b9e87-9563-4403-89ad-cfa3282a1ba5)
- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/specialty-blood-center/50b77d75-2d8f-4895-878d-e9b6bdfdafe3

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7