FDA-Inspected Site

Supernus Pharmaceuticals, Inc.

8 FDA inspections are on record for Supernus Pharmaceuticals, Inc. in Rockville, United States.

Clean· No action indicated

Rockville, United States · Last updated July 9, 2026

Overview

  • 8 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-07-31.

At a glance

Inspections

8

Form 483s

1

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Jul 2025 – 31 Jul 2025Human DrugsClean
7 Oct 2019 – 10 Oct 2019Human DrugsClean
8 Jul 2019 – 10 Jul 2019Human DrugsClean
31 Jan 2017 – 3 Feb 2017Human Drugs483View 483 →
18 Feb 2015 – 23 Feb 2015Human DrugsClean
17 Jun 2014 – 19 Jun 2014Human DrugsClean
9 Feb 2012Not recordedClean
3 Mar 2011Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

3 Feb 2017
21 CFR 314.80(c)(2)

Late submission of quarterly safety reports

Cited by Jonathan W Chapman, Chaltu N Wakijra

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 314.80(c)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Supernus Pharmaceuticals, Inc.'s 1 Form 483

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