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InVia Fertility Specialists, PLLC FDA Record

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

InVia Fertility Specialists, PLLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to InVia Fertility Specialists, PLLC, the most recent on Jun 13, 2025. FDA has published 1 Form 483 for InVia Fertility Specialists, PLLC.

What these totals cover: FDA records filed under the name "InVia Fertility Specialists, PLLC".

Latest inspection: Feb 5, 2025 · OAI

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	5	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

InVia Fertility Specialists, PLLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	1	1	1
2024	0	0	0
2023	0	0	0
2022	1	0	0
2021	0	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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InVia Fertility Specialists, PLLC FDA Warning Letters

1 warning letter on Jun 13, 2025.

Issued	Subject	Issuing office	Close-out letter
Jun 13, 2025 · Letter on fda.gov	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)	Center for Biologics Evaluation and Research

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.

InVia Fertility Specialists, PLLC Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Feb 5, 2025 · Document on fda.gov	483	3004744097

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

5 inspections from Jul 25, 2011 to Feb 5, 2025.

Date	Site	Product	Classification	FEI
Feb 5, 2025	Hoffman Estates, IL	Biologics	Official Action Indicated (OAI)	3004744097
Sep 9, 2022	Hoffman Estates, IL	Biologics	No Action Indicated (NAI)	3004744097
Jul 5, 2017	Hoffman Estates, IL	Biologics	No Action Indicated (NAI)	3004744097
Nov 12, 2015	Hoffman Estates, IL	Biologics	No Action Indicated (NAI)	3004744097
Jul 25, 2011	Hoffman Estates, IL	Biologics	No Action Indicated (NAI)	3004744097

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 InVia Fertility Specialists, PLLC: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jun 13, 2025.

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 3004744097	Hoffman Estates, IL	5	Feb 5, 2025

InVia Fertility Specialists, PLLC and the FDA: common questions

Has InVia Fertility Specialists, PLLC received an FDA warning letter?

Yes. FDA has issued 1 warning letter to InVia Fertility Specialists, PLLC. The most recent is dated Jun 13, 2025, with the subject "Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)".

Has InVia Fertility Specialists, PLLC received an FDA Form 483?

FDA has published 1 Form 483 for InVia Fertility Specialists, PLLC in its reading room, the most recent dated Feb 5, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect InVia Fertility Specialists, PLLC?

The most recent FDA inspection on file ended Feb 5, 2025 at Hoffman Estates, IL and was classified OAI. FDA has 5 inspections of InVia Fertility Specialists, PLLC on file, 1 of them classified OAI (official action indicated).

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