Home / Companies / American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.

American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. FDA Record

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

Latest inspection VAI · Jun 9, 2022
Last warning letter 2020

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Apr 2, 2020

510(k) clearances 0 None on file

American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc., the most recent on Apr 2, 2020.

What these totals cover: FDA records filed under the name "American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc." and its spelling variant "American Fertility Medical Center - Genetic Infertility And Andrology Laboratory".

Latest inspection: Jun 9, 2022 · 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	3	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

American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	1	0	0
2021	1	0	0
2020	1	1	1
2019	0	0	0
2018	0	0	0
2017	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.

Reviewing American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. FDA Warning Letters

1 warning letter on Apr 2, 2020.

Issued	Subject	Issuing office	Close-out letter
Apr 2, 2020 · 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

3 inspections from Jan 22, 2020 to Jun 9, 2022.

Date	Site	Product	Classification	FEI
Jun 9, 2022	Irvine, CA	Biologics	Voluntary Action Indicated (VAI)	3015417637
Aug 2, 2021	Irvine, CA	Biologics	No Action Indicated (NAI)	3015417637
Jan 22, 2020	Irvine, CA	Biologics	Official Action Indicated (OAI)	3015417637

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 American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Apr 2, 2020.

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 3015417637	Irvine, CA	3	Jun 9, 2022

American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. and the FDA: common questions

Has American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.. The most recent is dated Apr 2, 2020.

Has American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc.?

The most recent FDA inspection on file ended Jun 9, 2022 at Irvine, CA and was classified VAI. FDA has 3 inspections of American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.