Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-19.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jan 2024 – 19 Jan 2024 | Human Drugs | Clean | |
| 6 Nov 2018 – 27 Nov 2018 | Human Drugs | Clean | |
| 11 Oct 2016 – 17 Oct 2016 | Human Drugs | Clean | |
| 11 Mar 2015 – 19 Mar 2015 | Animal Drugs & Feeds | 483 | On file |
| 27 Nov 2012 | Not recorded | 483 | View 483 → |
| 4 Apr 2011 | Not recorded | 483 | View 483 → |
| 23 Mar 2010 | 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.
Courtney R Tiegs2 insp.
Marie A Fadden2 insp.
Kevin P Regan1 insp.
Soyinka S Eneng1 insp.
Beatrix D Arevalo1 insp.
Beatrix D Hippe1 insp.
Anthony J Ladner1 insp.
Courtney R Ingalsbe1 insp.
Scott A Golladay1 insp.
April L Young1 insp.
Ivan E Reyes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aurora Pharmaceutical, Inc., DBA Jefferson Labs' 3 Form 483s
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