Overview
- 12 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-02-10.
At a glance
Inspections
12
Form 483s
8
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Feb 2020 – 10 Feb 2020 | Human Drugs | Clean | |
| 5 Aug 2019 – 12 Aug 2019 | Human Drugs | 483 | View 483 → |
| 17 Dec 2018 – 21 Dec 2018 | Human Drugs | 483 | View 483 → |
| 15 Nov 2017 – 22 Nov 2017 | Human Drugs | 483 | View 483 → |
| 13 Jul 2015 – 17 Jul 2015 | Human Drugs | 483 | View 483 → |
| 19 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jun 2013 – 12 Jun 2013 | Human Drugs | 483 | View 483 → |
| 25 Aug 2011 | Not recorded | 483 | View 483 → |
| 14 Apr 2010 | Not recorded | 483 | On file |
| 31 Mar 2008 | Not recorded | Clean | |
| 13 Nov 2006 | Not recorded | Clean | |
| 9 Nov 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Aug 2019
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Zachary L Stamm, Jamie L Dion
12 Aug 2019
21 CFR 211.192
Written record of investigation incomplete
Cited by Zachary L Stamm, Jamie L Dion
Investigators
FDA investigators tied to this site in the record.
Erika V Butler2 insp.
Zachary L Stamm2 insp.
Jamie L Dion2 insp.
Zachery L Miller2 insp.
Dustin M James1 insp.
Genoula K Ryan1 insp.
Alan P Kurtzberg1 insp.
Chelsea N Sealey1 insp.
Ashleigh P Wodushek1 insp.
Matthew R Dionne1 insp.
Kimetha A King1 insp.
Theressa B Smith1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.105(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.46(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Septodont Inc.'s 8 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