Overview
- 8 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-12-19.
At a glance
Inspections
8
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Nov 2018 – 19 Dec 2018 | Foods & Cosmetics | 483 | View 483 → |
| 2 Dec 2015 – 10 Dec 2015 | Human Drugs | Clean | |
| 19 Feb 2013 – 1 Mar 2013 | Human Drugs | Clean | |
| 22 Feb 2011 | Not recorded | 483 | On file |
| 29 Sep 2010 | Not recorded | Clean | |
| 25 Sep 2008 | Not recorded | Clean | |
| 21 Jun 2007 | Not recorded | Clean | |
| 10 Mar 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2018
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
19 Dec 2018
21 CFR 111.65
Quality control - quality, dietary supplement
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
19 Dec 2018
21 CFR 211.182
Personnel dating/signing equipment log
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
19 Dec 2018
21 CFR 211.182
Personnel dating/signing equipment log
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
19 Dec 2018
21 CFR 211.188(b)(3)
Identification of each component or in-process material
Cited by Ross J Grigsby, Courtney R Ingalsbe, Scott A Golladay
Investigators
FDA investigators tied to this site in the record.
Marie A Fadden3 insp.
April L Young2 insp.
Ross J Grigsby1 insp.
Courtney R Ingalsbe1 insp.
Scott A Golladay1 insp.
Nicole C Victoria1 insp.
Anthony J Ladner1 insp.
Courtney R Tiegs1 insp.
Ivan E Reyes1 insp.
David B Wieneke1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Upsher Smith Laboratories, Inc.'s 2 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