Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-30.
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 |
|---|---|---|---|
| 30 Nov 2023 | Biologics | Clean | |
| 20 Dec 2018 – 21 Dec 2018 | Biologics | Clean | |
| 19 Jan 2017 | Biologics | Clean | |
| 4 Mar 2015 | Biologics | Clean | |
| 14 Nov 2012 | Not recorded | 483 | View 483 → |
| 1 Dec 2010 | Not recorded | Clean | |
| 20 Nov 2008 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Nov 2008
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Catherine V Quinlan, Gary D Urbiel Goldner
20 Nov 2008
21 CFR 1271.47(e)
Adopting procedures from another organization
Cited by Catherine V Quinlan, Gary D Urbiel Goldner
Investigators
FDA investigators tied to this site in the record.
Matthew J Gretkierewicz2 insp.
Neali H Lucas2 insp.
Erma Zaimova1 insp.
Barbara A Rusin1 insp.
Sherri J Jackson1 insp.
Catherine V Quinlan1 insp.
Gary D Urbiel Goldner1 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 1271.47(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.47(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Henry Ford 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