Atlas

Form 483

Novo Nordisk Inc. Form 483, 2017-04-13

FDA issued a Form 483 to Novo Nordisk Inc. on 2017-04-13 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Novo Nordisk Inc. · Plainsboro, United States · Issued April 13, 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.

13 Apr 2017
21 CFR 312.50

General responsibilities of sponsors

Cited by Michael Serrano, Shirley S Wen

Inspected site

NNNovo Nordisk Inc.Plainsboro, United States

Inspection team

MSMichael Serrano
SSShirley S Wen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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