Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-06-06.
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 |
|---|---|---|---|
| 6 Jun 2023 | Biologics | Clean | |
| 31 Jul 2019 | Biologics | Clean | |
| 9 Mar 2017 – 16 Mar 2017 | Biologics | 483 | View 483 → |
| 9 Mar 2015 – 10 Mar 2015 | Biologics | Clean | |
| 15 Jan 2013 | Not recorded | Clean | |
| 4 Feb 2011 | Not recorded | 483 | View 483 → |
| 11 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Feb 2011
21 CFR 1271.195(b)
Periodic inspection
Investigators
FDA investigators tied to this site in the record.
Jennifer L Sheehan3 insp.
Craig T Rybus1 insp.
Lindsey M Schwierjohann1 insp.
Jennifer L Jager1 insp.
Thunder N Dunkijacobs1 insp.
Christopher T Middendorf1 insp.
Thomas W Nojek1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(d)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.195(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind LifeCenter Organ Donor Network'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