Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-06-13.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jun 2025 – 13 Jun 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Mar 2018 – 22 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 11 Sep 2014 – 15 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 22 Sep 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2025
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by David M Wilkinson
13 Jun 2025
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by David M Wilkinson
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 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Ion Medical, Inc.'s 1 Form 483
Source PDFs 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