Atlas

Form 483

Aurora Pharmaceutical, Inc., DBA Jefferson Labs Form 483, 2012-11-27

FDA issued a Form 483 to Aurora Pharmaceutical, Inc., DBA Jefferson Labs on 2012-11-27 with 3 public-safe observations.

483· Form 483 issued3 observations

Aurora Pharmaceutical, Inc., DBA Jefferson Labs · Northfield, United States · Issued November 27, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

27 Nov 2012
21 CFR 211.94(b)

Protection from external factors

Cited by April L Young

27 Nov 2012
21 CFR 211.110(b)

In-process materials specifications

Cited by April L Young

27 Nov 2012
21 CFR 211.110(c)

In-process materials characteristics testing

Cited by April L Young

Inspected site

APAurora Pharmaceutical, Inc., DBA Jefferson LabsNorthfield, United States

Inspection team

ALApril L Young

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.94(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

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