Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-31.
At a glance
Inspections
13
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 31 Mar 2026 | Biologics | Clean | |
| 15 Dec 2025 – 19 Dec 2025 | Biologics | 483 | On file |
| 6 Oct 2025 – 10 Oct 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Aug 2025 – 21 Aug 2025 | Medical Devices & Rad Health | Clean | |
| 15 Nov 2021 – 16 Nov 2021 | Medical Devices & Rad Health | Clean | |
| 14 Sep 2017 – 21 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 11 Jul 2014 – 15 Jul 2014 | Medical Devices & Rad Health | Clean | |
| 20 May 2013 | Medical Devices & Rad Health | Clean | |
| 8 Apr 2013 | Medical Devices & Rad Health | Clean | |
| 2 Jun 2011 | Not recorded | 483 | On file |
| 10 May 2010 | Not recorded | 483 | View 483 → |
| 4 Feb 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Oct 2025
21 CFR 812.150(b)(5)
Sponsor progress reports for significant risk study
Cited by Dina A Tallman
Investigators
FDA investigators tied to this site in the record.
Ralph W Jerndal2 insp.
Danielle R Rainey1 insp.
Ou Ma1 insp.
Shaina R Fullwood1 insp.
Silvia H De Paoli1 insp.
Dina A Tallman1 insp.
Benjamin W Anderson1 insp.
Christina L Bigham1 insp.
Tyler R Courtney1 insp.
James A Beaulieu1 insp.
Yehualashe A Gessesse1 insp.
Susan M Matthias1 insp.
Denise L Burosh1 insp.
Paola E Lathrop1 insp.
Tony T Yang1 insp.
Tracy A Solseng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.150(b)(5) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 812.140(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.43(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 4 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