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Form 483

Supernus Pharmaceuticals, Inc. Form 483, 2017-02-03

FDA issued a Form 483 to Supernus Pharmaceuticals, Inc. on 2017-02-03 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Supernus Pharmaceuticals, Inc. · Rockville, United States · Issued February 3, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Late submission of quarterly safety reports

Cited by Jonathan W Chapman, Chaltu N Wakijra

Inspected site

SPSupernus Pharmaceuticals, Inc.Rockville, United States

Inspection team

JWJonathan W Chapman
CNChaltu N Wakijra

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere