Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-05-16.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 16 May 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Dec 2022 – 8 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 19 Feb 2020 – 21 Feb 2020 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 May 2024
21 CFR 812.100
Investigator non-compliance with agreement/plan/regulations
Cited by Kellie R Riggs
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 812.100 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Kenneth B. Strenge, MD'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