# FDA 483 - Kedplasma LLC - April 22, 2022

Source: https://www.globalkeysolutions.net/records/483/kedplasma-llc/7d11ec9a-5f83-4c29-9b38-63c50cc844d1

> FDA 483 for Kedplasma LLC on April 22, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kedplasma LLC
- Inspection Date: 2022-04-22
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: BPL Plasma, Inc. in Hot Springs, AR, a Source Plasma Collection Center, was cited for failing to adequately assess donor medical history. Specifically, their medical questionnaire and travel poster did not sufficiently screen donors for Creutzfeldt-Jacob Disease (CJD) and Variant Creutzfeld-Jacob Disease (vCJD) risks associated with travel to high-risk areas. This deficiency could adversely affect the safety, purity, or potency of collected blood components.

## Related Officers

- [Bobbi Miller](https://www.globalkeysolutions.net/people/bobbi-miller/60517ce9-0fee-4099-98ef-c7329af0518a)
- [investigator](https://www.globalkeysolutions.net/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.globalkeysolutions.net/companies/kedplasma-llc/e11a991a-9056-487b-9591-27fa06ab1a09

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab