Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-29.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2025 – 29 Jan 2025 | Biologics | Clean | |
| 25 Jun 2019 – 27 Jun 2019 | Biologics | Clean | |
| 27 Apr 2016 – 28 Apr 2016 | Biologics | Clean | |
| 26 Aug 2014 – 27 Aug 2014 | Biologics | Clean | |
| 6 Aug 2013 – 14 Aug 2013 | Biologics | 483 | View 483 → |
| 15 Feb 2012 | Not recorded | 483 | View 483 → |
| 24 May 2011 | Not recorded | WL | View 483 → |
| 20 Nov 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Aug 2013
21 CFR 1271.47(a)
Procedures for all other requirements
Cited by Peter S Kessler, Dianna D Wardlow-Dotter
15 Feb 2012
21 CFR 1271.47(a)
Design of procedures to ensure compliance
Cited by Alexander M Kay, Dianna D Wardlow-Dotter
15 Feb 2012
21 CFR 1271.60(b)
Identified as quarantined, distinguishable
Cited by Alexander M Kay, Dianna D Wardlow-Dotter
15 Feb 2012
21 CFR 1271.75(d)
Donors with risks not determined ineligible
Cited by Alexander M Kay, Dianna D Wardlow-Dotter
Investigators
FDA investigators tied to this site in the record.
Peter S Kessler3 insp.
Dianna D Wardlow-Dotter3 insp.
Vanessa Y Jacobs2 insp.
Vanessa Y Gelsey2 insp.
Alexander M Kay2 insp.
Sunitha K Rajaram1 insp.
Ounchith J Phabmixay1 insp.
Dolores E Price1 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 1271.75(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.75(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.65(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.80(d)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Seattle Sperm Bank LLC'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