Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-20.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Aug 2025 – 20 Aug 2025 | Biologics | Clean | |
| 24 Jun 2022 – 27 Jun 2022 | Biologics | Clean | |
| 5 Apr 2018 | Biologics | Clean | |
| 17 Mar 2016 | Biologics | Clean | |
| 12 Mar 2014 – 13 Mar 2014 | Biologics | 483 | View 483 → |
| 14 Mar 2012 | Not recorded | Clean | |
| 17 Dec 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Mar 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Eric A Breselow, Denise L Burosh
17 Dec 2009
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Michelle J Glembin
Investigators
FDA investigators tied to this site in the record.
Denise L Burosh2 insp.
Marlene L Davis1 insp.
Robert M Tillman1 insp.
Susan M Miller1 insp.
Susan M North1 insp.
Eric A Breselow1 insp.
Melissa J Holz1 insp.
Michelle J Glembin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Versiti Wisconsin Inc. - Transfusion Service's 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat