# FDA 483 - KEDPLASMA LLC - December 16, 2025

Source: https://www.keypedia.com/records/483/kedplasma-llc/b532d7a8-22a4-444b-8c94-5e839c0853b1

> FDA 483 for KEDPLASMA LLC on December 16, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: KEDPLASMA LLC
- Inspection Date: 2025-12-16
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of KEDPLASMA LLC in Indianapolis, IN, revealed two significant observations. The firm failed to correctly label Source Plasma containers with the total plasma volume and exhibited a critical lapse in aseptic technique during blood collection, where a phlebotomist contaminated a sterile venipuncture site.

## Related Documents

- [483 - 2025-12-16](https://www.keypedia.com/records/483/kedplasma-llc/cd2942ec-2a67-40a2-9e51-3de71cd5fb94)

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/kedplasma-llc/123cff5f-7813-4ac1-b0c1-d8189cb1ac44

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0