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Louisiana State University Health Sciences Center IRB FDA Record

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

Latest inspection OAI · Jul 26, 2023
Last warning letter 2024

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 27, 2024

510(k) clearances 0 None on file

Louisiana State University Health Sciences Center IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Louisiana State University Health Sciences Center IRB, the most recent on Sep 27, 2024.

What these totals cover: FDA records filed under the name "Louisiana State University Health Sciences Center IRB".

Latest inspection: Jul 26, 2023 · OAI

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

Louisiana State University Health Sciences Center IRB's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Louisiana State University Health Sciences Center IRB: FDA inspections per year

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

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Louisiana State University Health Sciences Center IRB FDA Warning Letters

1 warning letter on Sep 27, 2024.

Issued	Subject	Issuing office	Close-out letter
Sep 27, 2024 · 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 Mar 24, 2010 to Jul 26, 2023.

Date	Site	Product	Classification	FEI
Jul 26, 2023	New Orleans, LA	Devices	Official Action Indicated (OAI)	2310620
Sep 23, 2016	New Orleans, LA	Drugs	No Action Indicated (NAI)	2310620
Mar 24, 2010	New Orleans, LA	Devices	No Action Indicated (NAI)	2310620

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 Louisiana State University Health Sciences Center IRB: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 27, 2024.

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 2310620	New Orleans, LA	3	Jul 26, 2023

Louisiana State University Health Sciences Center IRB and the FDA: common questions

Has Louisiana State University Health Sciences Center IRB received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Louisiana State University Health Sciences Center IRB. The most recent is dated Sep 27, 2024.

Has Louisiana State University Health Sciences Center IRB received an FDA Form 483?

FDA has not published a Form 483 for "Louisiana State University Health Sciences Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Louisiana State University Health Sciences Center IRB?

The most recent FDA inspection on file ended Jul 26, 2023 at New Orleans, LA and was classified OAI. FDA has 3 inspections of Louisiana State University Health Sciences Center IRB on file, 1 of them classified OAI (official action indicated).

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