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Onto Fertility Of Colorado PC FDA Record

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

Latest inspection NAI · Jun 26, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Onto Fertility Of Colorado PC has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Onto Fertility Of Colorado PC" is on file.

What these totals cover: FDA records filed under the name "Onto Fertility Of Colorado PC".

Latest inspection: Jun 26, 2025 · NAI

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	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Onto Fertility Of Colorado PC: 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	1	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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Recent FDA inspections

7 inspections from Dec 7, 2009 to Jun 26, 2025.

Date	Site	Product	Classification	FEI
Jun 26, 2025	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604
Mar 29, 2019	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604
Nov 15, 2016	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604
Oct 6, 2014	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604
Jan 3, 2013	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604
Mar 16, 2011	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604
Dec 7, 2009	Parker, CO	Biologics	No Action Indicated (NAI)	3007374604

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.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3007374604	Parker, CO	7	Jun 26, 2025

Onto Fertility Of Colorado PC and the FDA: common questions

Has Onto Fertility Of Colorado PC received an FDA warning letter?

No FDA warning letter addressed to the name "Onto Fertility Of Colorado PC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Onto Fertility Of Colorado PC received an FDA Form 483?

FDA has not published a Form 483 for "Onto Fertility Of Colorado PC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Onto Fertility Of Colorado PC?

The most recent FDA inspection on file ended Jun 26, 2025 at Parker, CO and was classified NAI. FDA has 7 inspections of Onto Fertility Of Colorado PC on file.

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