Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2020-06-03.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 May 2020 – 3 Jun 2020 | Human Drugs | Clean | |
| 16 Sep 2019 – 26 Sep 2019 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2019
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Myra K Casey, Saikat I Bhuiyan
26 Sep 2019
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Myra K Casey, Saikat I Bhuiyan
Investigators
FDA investigators tied to this site in the record.
Myra K Casey2 insp.
Saikat I Bhuiyan1 insp.
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 | 2x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Scott T. Guenthner M.D.'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