Atlas

Form 483

Novo Nordisk A/S Form 483, 2011-09-08

FDA issued a Form 483 to Novo Nordisk A/S on 2011-09-08 with 2 public-safe observations.

483· Form 483 issued2 observations

Novo Nordisk A/S · Malov, Denmark · Issued September 8, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

8 Sep 2011
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Don H Bark, Rachel C Harrington

8 Sep 2011
21 CFR 211.165(a)

Testing and release for distribution

Cited by Don H Bark, Rachel C Harrington

Inspected site

NNNovo Nordisk A/SMalov, Denmark

Inspection team

DHDon H Bark
RCRachel C Harrington

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)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