# KEDPLASMA LLC – FDA 483, Jul 30, 2026

Source: https://www.keypedia.com/records/483/kedplasma-llc/e4246f86-e6e4-4cf5-8cd6-2e6ee6292046

> FDA 483 for KEDPLASMA LLC on July 30, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KEDPLASMA LLC
- Inspection Date: 2026-07-30
- Product Type: biologics
- Office Name: Denver District Office
- Summary: KEDPLASMA LLC in Goodyear, AZ, a plasmapheresis collection center, was cited for three observations during an FDA inspection. The findings included failures to adequately explain plasmapheresis risks to donors, non-adherence to standard operating procedures during donor physical examinations, and deficiencies in the scheduled calibration and preventative maintenance of collection equipment. These issues indicate a need for improved procedural compliance and equipment management.

## Related Officers

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

Company: https://www.keypedia.com/companies/kedplasma-llc/ae33cabf-3171-4b60-b70a-48618a540c1c

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face