# FDA 483 - Kedplasma LLC - Unknown Date

Source: https://www.keypedia.com/records/483/kedplasma-llc/13969a6b-c08d-4338-a6fb-e59e3f6b0e5e

> 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: Office of Medical Device and Radiological Health Operations
- Summary: KEDPLASMA LLC in Orlando, FL, was issued a Form 483 following an inspection from February 2-3, 2026. The inspection identified a failure to adhere to established procedures designed to ensure donor safety and program compliance. Specifically, a donor in an immunization program did not receive required physical examinations, even when a system prompt indicated the exam was overdue.

## Related Officers

- [Mona B. Amin](https://www.keypedia.com/people/mona-b-amin/680e7842-1b89-48dc-b317-11d4a77ac0f5)
- [Catherine McDevitt](https://www.keypedia.com/people/catherine-mcdevitt/83d2f522-88ef-44be-82f9-24ddb8e6abf5)
- [Christi Ann L. Samella](https://www.keypedia.com/people/christi-ann-l-samella/71bfa6f5-fa6c-48b9-866d-3ae61565eb2e)

Company: https://www.keypedia.com/companies/kedplasma-llc/73a73078-11e9-4203-b5b6-9ddf25db74a4

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4