Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-12.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Dec 2024 – 12 Dec 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jun 2024 – 6 Jun 2024 | Human Drugs | Clean | |
| 13 Feb 2023 – 16 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Feb 2022 – 18 Feb 2022 | Medical Devices & Rad Health | Clean | |
| 29 Oct 2019 – 4 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Jun 2015 – 2 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 16 Jan 2013 | Not recorded | Clean | |
| 11 Apr 2011 | Not recorded | Clean | |
| 13 Mar 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Kwong P Lee2 insp.
Jacqueline S Warner2 insp.
Gregson A Joseph2 insp.
Paul E Stein2 insp.
Pushpa S Jayasekara1 insp.
Alisha B Patel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Isomedix Operations Inc.'s 3 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