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Versiti Indiana Inc. FDA Inspection Record

FEI 3015387520 · Inspections, Form 483s, warning letters and import refusals

Versiti Indiana Inc. is an FDA-inspected facility (FEI 3015387520) located in Columbus, OH, US. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Oct 18, 2023: No Action Indicated (NAI)
Inspections on record
3 (3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
10, latest Feb 29, 2024

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Oct 18, 2023No Action Indicated (NAI)No citations listed
Sep 26, 2022No Action Indicated (NAI)No citations listed
Jan 15, 2020No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Feb 29, 2024Class IIB-0268-2024Apheresis Platelets, Leukocytes Reduced, Irradiated
Leukoreduced Apheresis Platelets, Irradiated, in which the platelet yield did not meet specifications, were distributed.
Dec 29, 2023Class IIIB-0186-2024Red Blood Cells, Leukocytes Reduced
Red Blood Cell products, for which a visual inspection was not performed or documented, were distributed.
Nov 4, 2023Class IIIB-0131-2024Red Blood Cells, Leukocytes Reduced
Red Blood Cell product for which a visual inspection was not performed or documented, was distributed.
Sep 14, 2023Class IIIB-0037-2024Red Blood Cells, Leukocytes Reduced, Irradiated
Leukoreduced Red Blood Cells, Irradiated, which were labeled with the incorrect expiration date, were distributed.
Aug 22, 2023Class IIB-0011-2024Red Blood Cells, Leukocytes Reduced, Irradiated
Leukoreduced Red Blood Cells, Irradiated, with potential over exposure to irradiation, were distributed.
Aug 9, 2023Class IIB-0659-2023Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated and 1 more product
Blood products, which were possibly exposed to unacceptable shipping temperatures, were distributed.
Jun 22, 2022Class IIB-0197-2023Red Blood Cells, Leukocytes Reduced, Irradiated
Leukoreduced Red Blood Cells, Irradiated, for which documentation of irradiation was incomplete, were distributed.
Feb 2, 2022Class IIIB-0285-2022Apheresis PLATELETS|ACD-A/XX/20-24C|Irradiated|ResLeu:<5E6|3rd container|<3E11…
Blood Products, which were irradiated longer than the allowed time frame, were distributed.
Jul 9, 2020Class IIIB-0642-2020Red Blood Cells, Leukocytes Reduced, Irradiated and 1 more product
Red Blood Cell products, identified as unsuitable due to a component preparation deviation or unexpected event, were distributed.
Mar 2, 2020Class IIIB-0442-2020Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells were distributed without a final visual check.

FDA record score

10 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0268-2024, this FEI as the recalling firmFeb 29, 20244 x 0.62.4
Class II recall B-0011-2024, this FEI as the recalling firmAug 22, 20234 x 0.62.4
Class II recall B-0659-2023, this FEI as the recalling firmAug 9, 20234 x 0.62.4
Class II recall B-0197-2023, this FEI as the recalling firmJun 22, 20224 x 0.62.4

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Versiti Indiana Inc.
Location
Columbus, OH (US)
Source
inspections

FDA data resources

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