Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-06.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2025 | Biologics | Clean | |
| 2 Oct 2019 | Biologics | Clean | |
| 31 Aug 2017 – 1 Sep 2017 | Biologics | Clean | |
| 29 Jul 2014 – 31 Jul 2014 | Biologics | Clean | |
| 6 Aug 2012 | Not recorded | 483 | View 483 → |
| 16 Mar 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Aug 2012
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Sandra Sejdinovic
16 Mar 2010
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Karen M Labounty, Paola E Lathrop
16 Mar 2010
21 CFR 1271.80(c)
Kits not FDA approved, specifically labeled
Cited by Karen M Labounty, Paola E Lathrop
Investigators
FDA investigators tied to this site in the record.
Melissa D Kalik2 insp.
Sandra Sejdinovic2 insp.
Kellie L Thommes1 insp.
Karen M Labounty1 insp.
Paola E Lathrop1 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 | 2x |
| 21 CFR 1271.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Center for Reproductive Medicine'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