KEDPLASMA LLC
Form 483 issued December 16, 2025
- Inspection
- Dec 9 – Dec 16, 2025
- Investigator
- Lesley Mae P. Lutao
- Observations
- 2
- Pages
- 3
- FEI number
- 3024967183
In short: On December 16, 2025, FDA issued a Form 483 with 2 observations to KEDPLASMA LLC (FEI 3024967183) after an inspection that ran Dec 9 – Dec 16, 2025. The investigator was Lesley Mae P. Lutao. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.121 (container label).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.121 (1×) · 640.64 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 606.121
The container label of Source Plasma fails to include the total volume or weight of plasma…
- 02
Failure to collect blood by aseptic methods…
This inspection in context
Lesley Mae P. Lutao
4 documents · 2024–2026
Cites 1271.220(c) (processing and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmKEDPLASMA LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 640.64
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at KEDPLASMA LLC?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.121 (container label). The opening words of each observation are shown on this page.
Who inspected KEDPLASMA LLC?
Lesley Mae P. Lutao is named on this Form 483, for the inspection of Dec 9 – Dec 16, 2025. Each investigator has a profile showing what they cite most.
When was KEDPLASMA LLC inspected by FDA?
The inspection ran Dec 9 – Dec 16, 2025, and the Form 483 is dated December 16, 2025.
How do I get the full Form 483 for KEDPLASMA LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.