Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-03-12.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Mar 2019 – 12 Mar 2019 | Human Drugs | 483 | View 483 → |
| 25 Jan 2017 – 30 Jan 2017 | Human Drugs | Clean | |
| 25 May 2016 – 2 Jun 2016 | Human Drugs | 483 | On file |
| 24 Feb 2012 | Not recorded | 483 | View 483 → |
| 1 Apr 2008 | Not recorded | 483 | On file |
| 26 Oct 2006 | Not recorded | Clean | |
| 19 Nov 2004 | Not recorded | Clean | |
| 19 Sep 2000 | 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.
Myra K Casey1 insp.
Sparky L Bartee1 insp.
Mark C Saale1 insp.
Comyar Shoghi1 insp.
Courtney N Long1 insp.
Linda Thai1 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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.62(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind William D Koltun, MD's 4 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