Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-01-13.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 | Biologics | Clean | |
| 15 May 2019 | Biologics | Clean | |
| 13 Dec 2016 | Biologics | Clean | |
| 1 Apr 2015 | Biologics | Clean | |
| 4 Sep 2013 – 5 Sep 2013 | Biologics | Clean | |
| 4 Jan 2011 | Not recorded | Clean | |
| 3 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Sep 2009
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Karen M Labounty, Darlene L Krieger
Investigators
FDA investigators tied to this site in the record.
Melissa D Kalik2 insp.
Sandra Sejdinovic2 insp.
Kellie L Thommes1 insp.
Kellie L Westerbuhr1 insp.
Karen M Labounty1 insp.
Darlene L Krieger1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.47(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind UMMC Diagnostic Andrology Lab's 1 Form 483
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