# FDA 483 - Specialty Blood Center - June 21, 2018

Source: https://www.keypedia.com/records/483/specialty-blood-center/4ec05d89-71d0-4bda-a8e3-52727dedfe27

> FDA 483 for Specialty Blood Center on June 21, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Specialty Blood Center
- Inspection Date: 2018-06-21
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Vitrologic, Inc., dba Specialty Sera, in Charleston, SC, was inspected and received a Form 483 with 10 observations. The inspection revealed significant deficiencies in donor management, including failure to notify deferred donors, maintain donor deferral records, and ensure donor safety during collection. Additionally, issues were noted in product labeling and the establishment and adherence to standard operating procedures for recordkeeping and emergency services.

## Related Documents

- [483 - 2019-12-16](https://www.keypedia.com/records/483/specialty-blood-center/f8a13820-2ed8-4b05-b421-dd0266afcb26)
- [483 - 2022-04-29](https://www.keypedia.com/records/483/specialty-blood-center/5a16548b-ae3b-4939-a02f-401cc3b01f14)

## Related Officers

- [investigator](https://www.keypedia.com/people/cordelia-j-brammer/57662881-a90a-461d-ac4d-8c1bc18a333e)
- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)

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