# FDA 483 - Kedplasma LLC - January 26, 2023

Source: https://www.globalkeysolutions.net/records/483/kedplasma-llc/bba5ee05-b3a7-48b2-b28a-e1f4b99f8d38

> FDA 483 for Kedplasma LLC on January 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kedplasma LLC
- Inspection Date: 2023-01-26
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of BFL Plasma, Inc. in Phoenix, AZ, from January 24-26, 2023, revealed a significant failure in determining donor suitability. Specifically, the firm allowed at least two donors to donate blood components despite incomplete health assessments, indicating a lapse in proper screening procedures and record-keeping.

## Related Officers

- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.globalkeysolutions.net/companies/kedplasma-llc/3f3aacfd-d14e-4ef0-9b1e-fd0853808e6a

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6