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Kofinas Fertility Group FDA Record

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

Kofinas Fertility Group has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Kofinas Fertility Group" is on file. FDA has published 1 Form 483 for Kofinas Fertility Group.

What these totals cover: FDA records filed under the name "Kofinas Fertility Group".

Latest inspection: Apr 9, 2025 · VAI

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

FDA record by year

Kofinas Fertility Group'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	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	1	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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Kofinas Fertility Group Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Apr 9, 2025 · Document on fda.gov	483	3004753467

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

8 inspections from Aug 19, 2009 to Apr 9, 2025.

Date	Site	Product	Classification	FEI
Apr 9, 2025	New York, NY	Biologics	Voluntary Action Indicated (VAI)	3004753467
Jul 25, 2023	New York, NY	Biologics	Voluntary Action Indicated (VAI)	3004753467
Feb 13, 2020	New York, NY	Biologics	No Action Indicated (NAI)	3004753467
Jun 25, 2018	New York, NY	Biologics	Voluntary Action Indicated (VAI)	3004753467
Mar 11, 2016	New York, NY	Biologics	No Action Indicated (NAI)	3004753467
Dec 4, 2013	New York, NY	Biologics	No Action Indicated (NAI)	3004753467
Sep 13, 2012	New York, NY	Biologics	No Action Indicated (NAI)	3004753467
Aug 19, 2009	New York, NY	Biologics	Voluntary Action Indicated (VAI)	3004753467

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 3004753467	New York, NY	8	Apr 9, 2025

Kofinas Fertility Group and the FDA: common questions

Has Kofinas Fertility Group received an FDA warning letter?

No FDA warning letter addressed to the name "Kofinas Fertility Group" 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 Kofinas Fertility Group received an FDA Form 483?

FDA has published 1 Form 483 for Kofinas Fertility Group in its reading room, the most recent dated Apr 9, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Kofinas Fertility Group?

The most recent FDA inspection on file ended Apr 9, 2025 at New York, NY and was classified VAI. FDA has 8 inspections of Kofinas Fertility Group on file.

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