Children's Hospital Colorado, Blood bank, Aurora, CO – FDA Inspections

Inspection records and compliance data for Children's Hospital Colorado, Blood bank in Aurora, Colorado. 8 FDA inspections on record (2 OAI), 1 Form 483, last inspected June 06, 2025.

Company Profile

This profile covers Children's Hospital Colorado, Blood bank based in Aurora, Colorado, United States.

FDA Inspection History

FDA inspections: 8
OAI: 2
VAI: 3
NAI: 2
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected February 10, 2010. Last inspected June 6, 2025.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs4 inspections
Donor suitability procedures not followed3 inspections
Person performing, test results, interpretation3 inspections

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
June 6, 2025	Not classified	Biologics	1274639
June 21, 2019	NAI	Human Drugs · Bioresearch Monitoring	1095304
May 10, 2019	NAI	Biologics · Blood and Blood Products	1094002
October 11, 2016	VAI	Biologics · Blood and Blood Products	991589
May 17, 2013	VAI	Biologics · Blood and Blood Products	833281
May 15, 2012	OAI	Biologics · Blood and Blood Products	780127
May 19, 2011	VAI	Biologics · Blood and Blood Products	726552
February 10, 2010	OAI	Biologics · Blood and Blood Products	644669

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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