Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-02-12.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Feb 2025 – 12 Feb 2025 | Biologics | Clean | |
| 1 Apr 2019 – 2 Apr 2019 | Biologics | Clean | |
| 11 Apr 2016 – 13 Apr 2016 | Biologics | Clean | |
| 10 Dec 2013 – 13 Dec 2013 | Biologics | 483 | View 483 → |
| 26 Aug 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Dec 2013
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Young M Yoon, Elisa M Fleming
13 Dec 2013
21 CFR 1271.55(c)
Name and personal info on accompanying records
Cited by Young M Yoon, Elisa M Fleming
13 Dec 2013
21 CFR 1271.55(d)(1)(iii)
Documentation--determination, by whom, date
Cited by Young M Yoon, Elisa M Fleming
13 Dec 2013
21 CFR 1271.65(a)
Improper release prevention--storage, I.D.
Cited by Young M Yoon, Elisa M Fleming
Investigators
FDA investigators tied to this site in the record.
Elmina E Akwo2 insp.
Ramon L Gonzalez-Prieto1 insp.
Elmina E Mboh1 insp.
Young M Yoon1 insp.
Elisa M Fleming1 insp.
Anya D Lockett-Evans1 insp.
Toby-Vern H Hill1 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 |
| 21 CFR 1271.55(c) | 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 |
Full site report
Get the verbatim findings behind The Center for Reproductive Endocrinology'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