Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-10-28.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Oct 2024 | Biologics | Clean | |
| 25 Mar 2022 – 28 Mar 2022 | Biologics | Clean | |
| 14 Aug 2017 | Biologics | Clean | |
| 23 Oct 2014 | Biologics | Clean | |
| 8 Apr 2014 | Biologics | Clean | |
| 8 Jul 2011 | Not recorded | 483 | View 483 → |
| 6 Sep 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Jul 2011
21 CFR 1271.200(c)
Calibration procedures and schedules (general)
Cited by Peter S Kessler, Alexander M Kay
Investigators
FDA investigators tied to this site in the record.
Peter S Kessler2 insp.
Alexander M Kay2 insp.
Kaarin M Slotte1 insp.
Elmina E Akwo1 insp.
Sarah J Cullen1 insp.
Vanessa Y Jacobs1 insp.
Vanessa Y Gelsey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1271.200(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.270(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Harborview Medical Center'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