Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-12-11.
At a glance
Inspections
9
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Dec 2024 – 11 Dec 2024 | Biologics | Clean | |
| 24 Jun 2019 | Biologics | Clean | |
| 14 Dec 2016 | Biologics | Clean | |
| 5 Nov 2014 – 6 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 26 Feb 2013 – 27 Feb 2013 | Human Drugs | Clean | |
| 27 Oct 2010 | Not recorded | Clean | |
| 29 Jul 2009 | Not recorded | Clean | |
| 26 Nov 2008 | Not recorded | 483 | View 483 → |
| 7 Jan 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Nov 2008
21 CFR 820.100(a)(6)
Dissemination of problem information
Cited by Sonya L Karsik, Brian P Putz
Investigators
FDA investigators tied to this site in the record.
Sonya L Karsik3 insp.
Celeta S Coves1 insp.
Doretha M Tonkins1 insp.
Jocelyn E Massey1 insp.
Binh T Nguyen1 insp.
Dejon N Harris1 insp.
Gene D Arcy1 insp.
Brian P Putz1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Isomedix Operations Inc.'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