Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-22.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Aug 2025 | Biologics | Clean | |
| 9 Dec 2019 | Biologics | Clean | |
| 7 Dec 2017 | Biologics | Clean | |
| 7 Dec 2015 – 8 Dec 2015 | Biologics | 483 | View 483 → |
| 7 Nov 2013 – 8 Nov 2013 | Biologics | Clean | |
| 11 Jan 2012 | Not recorded | 483 | View 483 → |
| 4 Feb 2010 | Not recorded | 483 | View 483 → |
| 13 May 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jan 2012
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Melissa J Holz
Investigators
FDA investigators tied to this site in the record.
Denise L Burosh4 insp.
Marlene L Davis1 insp.
Susan M North1 insp.
Lewis K Antwi1 insp.
Melissa J Holz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(d)(1)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Froedtert Hospital Reproductive Medicine Center's 3 Form 483s
Source PDFs, 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