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Richard L. Roudebush Veterans Affairs Medical Center FDA Record

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

Latest inspection NAI · May 15, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Richard L. Roudebush Veterans Affairs Medical Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Richard L. Roudebush Veterans Affairs Medical Center" is on file.

What these totals cover: FDA records filed under the name "Richard L. Roudebush Veterans Affairs Medical Center".

Latest inspection: May 15, 2025 · NAI

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	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Richard L. Roudebush Veterans Affairs Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Richard L. Roudebush Veterans Affairs Medical Center: FDA inspections per year

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	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	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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Recent FDA inspections

7 inspections from Jan 21, 2010 to May 15, 2025.

Date	Site	Product	Classification	FEI
May 15, 2025	Indianapolis, IN	Biologics	No Action Indicated (NAI)	1873082
Oct 12, 2022	Indianapolis, IN	Biologics	No Action Indicated (NAI)	1873082
Dec 12, 2017	Indianapolis, IN	Biologics	No Action Indicated (NAI)	1873082
Jan 6, 2016	Indianapolis, IN	Biologics	No Action Indicated (NAI)	1873082
Mar 27, 2014	Indianapolis, IN	Biologics	No Action Indicated (NAI)	1873082
Jan 11, 2012	Indianapolis, IN	Biologics	Voluntary Action Indicated (VAI)	1873082
Jan 21, 2010	Indianapolis, IN	Biologics	No Action Indicated (NAI)	1873082

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 1873082	Indianapolis, IN	7	May 15, 2025

Richard L. Roudebush Veterans Affairs Medical Center and the FDA: common questions

Has Richard L. Roudebush Veterans Affairs Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "Richard L. Roudebush Veterans Affairs Medical Center" 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 Richard L. Roudebush Veterans Affairs Medical Center received an FDA Form 483?

FDA has not published a Form 483 for "Richard L. Roudebush Veterans Affairs Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Richard L. Roudebush Veterans Affairs Medical Center?

The most recent FDA inspection on file ended May 15, 2025 at Indianapolis, IN and was classified NAI. FDA has 7 inspections of Richard L. Roudebush Veterans Affairs Medical Center on file.

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