Overview
- 13 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-25.
At a glance
Inspections
13
Form 483s
2
EIRs
6
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2025 – 25 Feb 2025 | Human Drugs | 483 | View 483 → |
| 22 Jan 2019 – 25 Jan 2019 | Human Drugs | Clean | |
| 9 Jul 2018 – 11 Jul 2018 | Human Drugs | Clean | |
| 15 May 2017 – 19 May 2017 | Human Drugs | Clean | |
| 3 Nov 2014 – 14 Nov 2014 | Medical Devices & Rad Health | 483 | On file |
| 16 Nov 2012 | Not recorded | Clean | |
| 21 Dec 2011 | Not recorded | Clean | |
| 17 Jun 2011 | Not recorded | Clean | |
| 20 Nov 2009 | Not recorded | Clean | |
| 25 Jul 2008 | Not recorded | Clean | |
| 18 Jan 2005 | Not recorded | Clean | |
| 12 Dec 2002 | 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.
Lauren N Howard2 insp.
Nicholas L Paulin2 insp.
Tracey L Harris2 insp.
Geoffrey K Kilili1 insp.
Jon P Antoniou1 insp.
Yvette M Lacour-Davis1 insp.
Heather A Mccauley1 insp.
Lauren N Smith1 insp.
Javonica F Penn1 insp.
Jennifer L Gustavus1 insp.
Elizabeth L Edwards1 insp.
Lindsey M Schwierjohann1 insp.
Anna M Brannen1 insp.
Mark E Parmon1 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 | 1x |
Full site report
Get the verbatim findings behind Adare Pharmaceuticals, Inc.'s 2 Form 483s
Source PDFs 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