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Colorado Center For Reproductive Medicine, LC FDA Record

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

Latest inspection VAI · Apr 12, 2024
Last warning letter 2023

Inspections 7

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jun 26, 2023

510(k) clearances 0 None on file

Colorado Center For Reproductive Medicine, LC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Colorado Center For Reproductive Medicine, LC, the most recent on Jun 26, 2023.

What these totals cover: FDA records filed under the name "Colorado Center For Reproductive Medicine, LC".

Latest inspection: Apr 12, 2024 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Colorado Center For Reproductive Medicine, LC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Colorado Center For Reproductive Medicine, LC: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	1	0	0
2023	1	1	1
2022	0	0	0
2021	1	0	0
2020	0	0	0
2019	0	0	0
2018	0	0	0
2017	1	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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Colorado Center For Reproductive Medicine, LC FDA Warning Letters

1 warning letter on Jun 26, 2023.

Issued	Subject	Issuing office	Close-out letter
Jun 26, 2023 · 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

7 inspections from Jun 19, 2012 to Apr 12, 2024.

Date	Site	Product	Classification	FEI
Apr 12, 2024	Virginia Beach, VA	Biologics	Voluntary Action Indicated (VAI)	3004731564
Jan 20, 2023	Virginia Beach, VA	Biologics	Official Action Indicated (OAI)	3004731564
May 12, 2021	Virginia Beach, VA	Biologics	No Action Indicated (NAI)	3004731564
Dec 6, 2017	Virginia Beach, VA	Biologics	No Action Indicated (NAI)	3004731564
Jun 2, 2016	Virginia Beach, VA	Biologics	No Action Indicated (NAI)	3004731564
Jun 2, 2014	Virginia Beach, VA	Biologics	No Action Indicated (NAI)	3004731564
Jun 19, 2012	Virginia Beach, VA	Biologics	No Action Indicated (NAI)	3004731564

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 Colorado Center For Reproductive Medicine, LC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 26, 2023.

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 3004731564	Virginia Beach, VA	7	Apr 12, 2024

Colorado Center For Reproductive Medicine, LC and the FDA: common questions

Has Colorado Center For Reproductive Medicine, LC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Colorado Center For Reproductive Medicine, LC. The most recent is dated Jun 26, 2023.

Has Colorado Center For Reproductive Medicine, LC received an FDA Form 483?

FDA has not published a Form 483 for "Colorado Center For Reproductive Medicine, LC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Colorado Center For Reproductive Medicine, LC?

The most recent FDA inspection on file ended Apr 12, 2024 at Virginia Beach, VA and was classified VAI. FDA has 7 inspections of Colorado Center For Reproductive Medicine, LC on file, 1 of them classified OAI (official action indicated).

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