# FDA 483 - KEDPlasma, LLC - November 10, 2022

Source: https://www.globalkeysolutions.net/records/483/kedplasma-llc/9fb2f3e0-ae68-4a9a-ba9e-f138e009e3dc

> FDA 483 for KEDPlasma, LLC on November 10, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KEDPlasma, LLC
- Inspection Date: 2022-11-10
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of KEDPLASMA, LLC in Pensacola, FL, a Source Plasma Establishment, revealed significant deficiencies in its quality system. The firm failed to adequately investigate major deviations and ensure the effectiveness of corrective and preventative actions. Additionally, employees did not consistently follow standard operating procedures for plasma collection, specifically concerning venipuncture site preparation and aseptic technique.

## Related Officers

- [Nisha C. Patel](https://www.globalkeysolutions.net/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

Company: https://www.globalkeysolutions.net/companies/kedplasma-llc/f2a2a9ec-e43c-4fdd-aa9c-fedb8df93507

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6