Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-21.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Feb 2025 – 21 Feb 2025 | Medical Devices & Rad Health | Clean | |
| 29 Mar 2022 – 12 Apr 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Nov 2019 – 7 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Apr 2022
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Jacqueline S Warner
7 Nov 2019
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Gregson A Joseph
7 Nov 2019
21 CFR 820.80(c)
Lack of or inadequate In-process acceptance procedures
Cited by Gregson A Joseph
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Isomedix Operations Inc.'s 2 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