Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-03-04.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2026 – 4 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Apr 2018 – 10 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 6 Nov 2012 | Not recorded | Clean | |
| 19 Mar 2010 | Not recorded | Clean | |
| 24 Jul 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Christina L Bigham
4 Mar 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Christina L Bigham1 insp.
Marissa S Steinhagen1 insp.
Susan M Matthias1 insp.
Marissa S Henning1 insp.
Jessica L Johnson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Radiation Products Design,Inc's 1 Form 483
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