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Children's Hospital Colorado FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Jun 6, 2025
Last warning letter 2010

Inspections 8

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 8, 2010

510(k) clearances 0 None on file

Children's Hospital Colorado has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Children's Hospital Colorado, the most recent on Apr 8, 2010.

What these totals cover: FDA records filed under the name "Children's Hospital Colorado" and its spelling variant "Children Hospital Colorado".

Latest inspection: Jun 6, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	8	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Children's Hospital Colorado's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Children's Hospital Colorado: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	2	0	0	0	0
2018	0	0	0	0	0
2017	0	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Children's Hospital Colorado FDA Warning Letters

1 warning letter on Apr 8, 2010.

Issued	Subject	Issuing office	Close-out letter
Apr 8, 2010 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

8 inspections from Feb 10, 2010 to Jun 6, 2025.

Date	Site	Product	Classification	FEI
Jun 6, 2025	Aurora, CO	Biologics	No Action Indicated (NAI)	1771443
Jun 21, 2019	Aurora, CO	Drugs	No Action Indicated (NAI)	1771443
May 10, 2019	Aurora, CO	Biologics	No Action Indicated (NAI)	1771443
Oct 11, 2016	Aurora, CO	Biologics	Voluntary Action Indicated (VAI)	1771443
May 17, 2013	Aurora, CO	Biologics	Voluntary Action Indicated (VAI)	1771443
May 15, 2012	Aurora, CO	Biologics	Official Action Indicated (OAI)	1771443
May 19, 2011	Aurora, CO	Biologics	Voluntary Action Indicated (VAI)	1771443
Feb 10, 2010	Aurora, CO	Biologics	Official Action Indicated (OAI)	1771443

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Children's Hospital Colorado: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 8, 2010.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1771443	Aurora, CO	8	Jun 6, 2025

Children's Hospital Colorado and the FDA: common questions

Has Children's Hospital Colorado received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Children's Hospital Colorado. The most recent is dated Apr 8, 2010.

Has Children's Hospital Colorado received an FDA Form 483?

FDA has not published a Form 483 for "Children's Hospital Colorado" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Children's Hospital Colorado?

The most recent FDA inspection on file ended Jun 6, 2025 at Aurora, CO and was classified NAI. FDA has 8 inspections of Children's Hospital Colorado on file, 2 of them classified OAI (official action indicated).

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