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FDA Inspection

KEDPLASMA LLCJuly 30, 2026

KEDPLASMA LLC – FDA Inspection, Jul 30, 2026

Record Details

This FDA Inspection record concerns KEDPLASMA LLC, with an inspection on July 30, 2026, issued by the Denver District Office, covering biologics.

Company: KEDPLASMA LLC
Inspection Date: July 30, 2026
Product Type: Biologics
Office: Denver District Office
Person: Emily S. McGann

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ID · 30de0880-bf75-49d6-81b4-e713c3e5fa31

Inspection Facts

Inspection number: 1328818
FDA center: Biologics
Project area: Blood and Blood Products
Outcome: Form 483 issued, view the record

FDA Citations

3

21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
21 CFR 606.60(a)Equipment observed, standardized, calibrated
21 CFR 630.15(b)(2)(iii)Risks and hazards

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Other FDA inspections of KEDPLASMA LLC

1

Date	Classification	Office	Project area
November 29, 2018	Not classified	Denver District Office

Other documents for KEDPLASMA LLC

FDA Inspection 1075131 - 2018-11-29

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