Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-22.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Mar 2023 – 22 Mar 2023 | Biologics | 483 | View 483 → |
| 23 Oct 2019 | Biologics | Clean | |
| 6 Nov 2017 – 7 Nov 2017 | Biologics | Clean | |
| 2 Dec 2015 – 4 Dec 2015 | Biologics | Clean | |
| 16 Dec 2013 – 17 Dec 2013 | Biologics | Clean | |
| 28 Dec 2011 | Not recorded | 483 | View 483 → |
| 21 Dec 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jennifer L Sheehan3 insp.
Thunder N Dunkijacobs2 insp.
Lindsey M Schwierjohann1 insp.
Jennifer L Jager1 insp.
Christopher T Middendorf1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.55(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.65(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.65(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.75(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Bethesda Fertility Center's 3 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