Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
3
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2026 – 24 Apr 2026 | Human Drugs | Clean | |
| 28 Jan 2015 – 2 Feb 2015 | Human Drugs | 483 | View 483 → |
| 22 May 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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 312.60 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Michael J. Koren, MD's 1 Form 483
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