Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-11-02.
At a glance
Inspections
4
Form 483s
3
EIRs
3
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Oct 2020 – 2 Nov 2020 | Biologics | Clean | |
| 8 Sep 2015 – 18 Sep 2015 | Human Drugs | 483 | View 483 → |
| 25 Jul 2012 | Not recorded | 483 | View 483 → |
| 27 Jan 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Sep 2015
21 CFR 312.62(b)
Case history records- inadequate or inadequate
Cited by Byungja E Marciante
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 | 2x |
| 21 CFR 312.62(a) | 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 David S. Siegel, M.D.'s 3 Form 483s
Source PDFs, 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