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Cooper Institute For Advanced Reproductive Medicine FDA Record

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

Latest inspection OAI · Nov 16, 2023
Last warning letter 2021

Inspections 5

3 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Nov 15, 2021

510(k) clearances 0 None on file

Cooper Institute For Advanced Reproductive Medicine has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Cooper Institute For Advanced Reproductive Medicine, the most recent on Nov 15, 2021.

What these totals cover: FDA records filed under the name "Cooper Institute For Advanced Reproductive Medicine".

Latest inspection: Nov 16, 2023 · 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 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

Cooper Institute For Advanced Reproductive Medicine: FDA inspections per year

Year	Inspections	OAI	Warning letters
2026	0	0	0
2025	0	0	0
2024	0	0	0
2023	1	1	0
2022	1	1	0
2021	1	1	1
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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Cooper Institute For Advanced Reproductive Medicine FDA Warning Letters

1 warning letter on Nov 15, 2021.

Issued	Subject	Issuing office	Close-out letter
Nov 15, 2021 · 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

5 inspections from Dec 22, 2014 to Nov 16, 2023.

Date	Site	Product	Classification	FEI
Nov 16, 2023	Houston, TX	Biologics	Official Action Indicated (OAI)	3011006339
Dec 9, 2022	Houston, TX	Biologics	Official Action Indicated (OAI)	3011006339
Jul 19, 2021	Houston, TX	Biologics	Official Action Indicated (OAI)	3011006339
Apr 26, 2017	Houston, TX	Biologics	No Action Indicated (NAI)	3011006339
Dec 22, 2014	Houston, TX	Biologics	Voluntary Action Indicated (VAI)	3011006339

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

Most recent: Warning Letter, Nov 15, 2021.

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 3011006339	Houston, TX	5	Nov 16, 2023

Cooper Institute For Advanced Reproductive Medicine and the FDA: common questions

Has Cooper Institute For Advanced Reproductive Medicine received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Cooper Institute For Advanced Reproductive Medicine. The most recent is dated Nov 15, 2021.

Has Cooper Institute For Advanced Reproductive Medicine received an FDA Form 483?

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

When did the FDA last inspect Cooper Institute For Advanced Reproductive Medicine?

The most recent FDA inspection on file ended Nov 16, 2023 at Houston, TX and was classified OAI. FDA has 5 inspections of Cooper Institute For Advanced Reproductive Medicine on file, 3 of them classified OAI (official action indicated).

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