# FDA 483 - KedPlasma LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/kedplasma-llc/7088b1be-7537-4eab-a8d1-8bb4e3cd4bb6

> FDA 483 for KedPlasma LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KedPlasma LLC
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: KEDPLASMA LLC, a plasmapheresis facility in Atlanta, Georgia, received a Form FDA 483 following an inspection from March 19-21, 2019. The inspection revealed two significant observations related to donor notification and adherence to standard operating procedures. Specifically, the firm failed to adequately notify deferred donors of all positive test results and did not consistently follow its SOPs for manufacturing Source Plasma, recordkeeping, equipment checks, and managing donor adverse events.

## Related Officers

- [Cordelia J. Brammer, Investigator, ORA](https://www.globalkeysolutions.net/people/cordelia-j-brammer-investigator-ora/c5ba4598-16d7-4e22-b00a-c22cd14a75b9)
- [Christopher Cox, Consumer Safety Officer, CBER](https://www.globalkeysolutions.net/people/christopher-cox-consumer-safety-officer-cber/cd7b6492-bf07-4e52-a189-231c7d125d56)
- [Judy Ellen Ciaraldi, Consumer Safety Officer, CBER](https://www.globalkeysolutions.net/people/judy-ellen-ciaraldi-consumer-safety-officer-cber/8eca0f21-e3a1-4534-8b0b-28623612f457)

Company: https://www.globalkeysolutions.net/companies/kedplasma-llc/9ec4a061-8bd5-4de8-b996-0e59e2824ef9

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd