Versiti Indiana, Inc. FDA Record

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

Versiti Indiana, Inc. has 0 FDA recalls, 33 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Versiti Indiana, Inc." is on file.

What these totals cover: FDA records filed under the name "Versiti Indiana, Inc." and its spelling variant "Versiti Indiana".

Latest inspection
Mar 11, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections33Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Versiti Indiana, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Versiti Indiana, Inc.: FDA inspections per year 2017: 2 inspections220172018: 2 inspections220182019: 0 inspections020192020: 2 inspections220202021: 1 inspections120212022: 1 inspections120222023: 2 inspections220232024: 3 inspections320242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202430000
202320000
202210000
202110000
202020000
201900000
201820000
201720000

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

33 inspections from Dec 3, 2009 to Mar 11, 2025. Showing the 20 most recent. View all 33 inspections

DateSiteProductClassificationFEI
Mar 11, 2025Lafayette, INBiologicsNo Action Indicated (NAI)1828129
Aug 8, 2024Dayton, OHBiologicsNo Action Indicated (NAI)1570984
Apr 25, 2024Indianapolis, INBiologicsNo Action Indicated (NAI)1876571
Feb 23, 2024Terre Haute, INBiologicsNo Action Indicated (NAI)1876566
Oct 18, 2023Columbus, OHBiologicsNo Action Indicated (NAI)3015387520
Aug 4, 2023Lafayette, INBiologicsNo Action Indicated (NAI)1828129
Sep 26, 2022Columbus, OHBiologicsNo Action Indicated (NAI)3015387520
Nov 2, 2021Dayton, OHBiologicsNo Action Indicated (NAI)1570984
Mar 16, 2020Terre Haute, INBiologicsNo Action Indicated (NAI)1876566
Jan 15, 2020Columbus, OHBiologicsNo Action Indicated (NAI)3015387520
Jun 29, 2018Dayton, OHBiologicsNo Action Indicated (NAI)1570984
May 23, 2018Indianapolis, INBiologicsNo Action Indicated (NAI)1876571
Dec 27, 2017Terre Haute, INBiologicsNo Action Indicated (NAI)1876566
Nov 1, 2017Lafayette, INBiologicsNo Action Indicated (NAI)1828129
Sep 21, 2016Dayton, OHBiologicsNo Action Indicated (NAI)1570984
Aug 11, 2016Indianapolis, INBiologicsNo Action Indicated (NAI)1876571
Feb 2, 2016Lafayette, INBiologicsNo Action Indicated (NAI)1828129
Dec 7, 2015Terre Haute, INBiologicsNo Action Indicated (NAI)1876566
Dec 18, 2014Indianapolis, INBiologicsNo Action Indicated (NAI)1876571
Jun 24, 2014Lafayette, INBiologicsNo Action Indicated (NAI)1828129
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

5 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 1828129Lafayette, IN7Mar 11, 2025
FEI 1570984Dayton, OH10Aug 8, 2024
FEI 1876571Indianapolis, IN6Apr 25, 2024
FEI 1876566Terre Haute, IN7Feb 23, 2024
FEI 3015387520Columbus, OH3Oct 18, 2023

Versiti Indiana, Inc. and the FDA: common questions

Has Versiti Indiana, Inc. received an FDA warning letter?

No FDA warning letter addressed to the name "Versiti Indiana, Inc." 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 Versiti Indiana, Inc. received an FDA Form 483?

FDA has not published a Form 483 for "Versiti Indiana, Inc." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Versiti Indiana, Inc.?

The most recent FDA inspection on file ended Mar 11, 2025 at Lafayette, IN and was classified NAI. FDA has 33 inspections of Versiti Indiana, Inc. on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.