Atlas

Form 483

Novo Nordisk A/S Form 483, 2012-04-30

FDA issued a Form 483 to Novo Nordisk A/S on 2012-04-30 with 2 public-safe observations.

483· Form 483 issued2 observations

Novo Nordisk A/S · Soborg, Denmark · Issued April 30, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

30 Apr 2012
21 CFR 312.50

General responsibilities of sponsors

Cited by Karen M Cooper

30 Apr 2012
21 CFR 312.56(b)

Investigator non-compliance

Cited by Karen M Cooper

Inspected site

NNNovo Nordisk A/SSoborg, Denmark

Inspection team

KMKaren M Cooper

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x
21 CFR 312.56(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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