# FDA 483 - KEDPLASMA LLC - December 16, 2025

Source: https://www.keypedia.com/records/483/kedplasma-llc/cd2942ec-2a67-40a2-9e51-3de71cd5fb94

> 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: Detroit District Office
- Summary: An FDA inspection of KEDPLASMA LLC in Indianapolis, IN, revealed two significant observations. The firm was cited for failing to include the total volume of plasma on Source Plasma container labels. Additionally, an observation was made regarding a phlebotomist's failure to maintain aseptic technique during arm preparation, leading to potential contamination.

## 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/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03