Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-03-01.
At a glance
Inspections
2
Form 483s
1
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Feb 2023 – 1 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Aug 2016 – 25 Aug 2016 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Mar 2023
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Brittany M Kershaw, Craig T Rybus, D'Arbra R Blankenship
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 812.110(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Michael J Rosen 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