Kedplasma LLC
Form 483 issued March 3, 2026
- Inspection
- Feb 24 – Mar 3, 2026
- Investigator
- Elyshia Q. Danaher
- Observations
- 1
- Pages
- 3
- FEI number
- 3014947536
In short: On March 3, 2026, FDA issued a Form 483 with 1 observation to Kedplasma LLC (FEI 3014947536) after an inspection that ran Feb 24 – Mar 3, 2026. The investigator was Elyshia Q. Danaher. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written standard operating procedures including all steps to be followed in the storage of blood and…
This inspection in context
Elyshia Q. Danaher
3 documents · 2025–2026
Cites 1271.55 (what records must accompany an hct/p after the donor-eligibility determination is complete; and what records must i retain?) more than any other section. Most of their documents are for sites in Texas.
The firmKedplasma LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kedplasma LLC?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Kedplasma LLC?
Elyshia Q. Danaher is named on this Form 483, for the inspection of Feb 24 – Mar 3, 2026. Each investigator has a profile showing what they cite most.
When was Kedplasma LLC inspected by FDA?
The inspection ran Feb 24 – Mar 3, 2026, and the Form 483 is dated March 3, 2026.
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.