Overview
- 13 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-10-17.
At a glance
Inspections
13
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Oct 2019 – 17 Oct 2019 | Human Drugs | 483 | View 483 → |
| 3 Nov 2015 – 23 Nov 2015 | Human Drugs | 483 | View 483 → |
| 25 Apr 2013 – 6 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jul 2011 | Not recorded | 483 | View 483 → |
| 14 Jun 2010 | Not recorded | Clean | |
| 3 Dec 2009 | Not recorded | Clean | |
| 28 Sep 2009 | Not recorded | Clean | |
| 31 Aug 2009 | Not recorded | 483 | On file |
| 10 Feb 2009 | Not recorded | Clean | |
| 21 Nov 2008 | Not recorded | Clean | |
| 29 May 2008 | Not recorded | 483 | On file |
| 23 Sep 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Nov 2015
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Darren S Brown, Carla J Lundi
23 Nov 2015
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Darren S Brown, Carla J Lundi
23 Nov 2015
21 CFR 211.84(d)(1)
Identity Testing of Each Component
Cited by Darren S Brown, Carla J Lundi
23 Nov 2015
21 CFR 310.305(a)
Failure to develop written procedures
Cited by Darren S Brown, Carla J Lundi
Investigators
FDA investigators tied to this site in the record.
Cntrctmntr Kelley4 insp.
Marcus F Yambot2 insp.
John A Gonzalez2 insp.
Diane R Weidley1 insp.
Darren S Brown1 insp.
Carla J Lundi1 insp.
Lilly O Barton1 insp.
Cntrctmntr Nepsa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 310.305(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Discus Dental LLC's 6 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