Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-06.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Mar 2025 – 6 Mar 2025 | Biologics | Clean | |
| 7 Nov 2018 | Biologics | Clean | |
| 3 Feb 2016 – 4 Feb 2016 | Biologics | 483 | View 483 → |
| 11 Feb 2013 – 12 Feb 2013 | Biologics | 483 | View 483 → |
| 20 May 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2013
21 CFR 1271.75(a)(1)
Risk factors, clinical evidence
Cited by Lauren E Skokan Priest, Lauren E Skokan
Investigators
FDA investigators tied to this site in the record.
Michelle Paxon1 insp.
Everard A Irish1 insp.
Kip J Hanks1 insp.
Decarlos A Gomez1 insp.
Yaw O Osei1 insp.
Lauren E Skokan Priest1 insp.
Lauren E Skokan1 insp.
Anya D Lockett-Evans1 insp.
Maira P Brading1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.90(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Texas Center for Reproductive Health'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