Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-29.
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 |
|---|---|---|---|
| 26 May 2026 – 29 May 2026 | Biologics | Clean | |
| 19 Nov 2018 – 27 Nov 2018 | Medical Devices & Rad Health | Clean | |
| 23 Jun 2014 – 27 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Oct 2009 | Not recorded | 483 | View 483 → |
| 25 Aug 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Oct 2009
21 CFR 56.108(a)(1)
Reporting findings and actions to investigator/institution
Cited by Michelle M Noe
Investigators
FDA investigators tied to this site in the record.
Meredith L Miller1 insp.
Michael P Anthony1 insp.
John L Zaccone1 insp.
Kent A Conforti1 insp.
Michelle M Noe1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 56.109(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.109(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 2 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