Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-28.
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 |
|---|---|---|---|
| 27 Jan 2025 – 28 Jan 2025 | Biologics | Clean | |
| 23 Aug 2021 – 25 Aug 2021 | Biologics | 483 | View 483 → |
| 8 Mar 2017 – 10 Mar 2017 | Biologics | Clean | |
| 19 Dec 2013 – 3 Jan 2014 | Biologics | 483 | View 483 → |
| 19 Jan 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2021
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Decarlos A Gomez
25 Aug 2021
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Decarlos A Gomez
25 Aug 2021
21 CFR 1271.47(a)
Testing, screening, donor eligibility procedures
Cited by Decarlos A Gomez
3 Jan 2014
21 CFR 1271.50(b)(2)
Donor testing not negative for CD agents
Cited by Patrice S Hall, Lauren E Skokan Priest
3 Jan 2014
21 CFR 1271.55(b)(1)
Statement re: certified testing lab
Cited by Patrice S Hall, Lauren E Skokan Priest
Investigators
FDA investigators tied to this site in the record.
Maira P Brading1 insp.
Michelle Paxon1 insp.
Decarlos A Gomez1 insp.
Elmina E Akwo1 insp.
Patrice S Hall1 insp.
Lauren E Skokan Priest1 insp.
Young M Yoon1 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 | 3x |
| 21 CFR 1271.50(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.55(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.85(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dallas Fertility Center - Baylor's 2 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