Atlas

Form 483

Daiichi Sankyo, Inc. Form 483, 2014-09-09

FDA issued a Form 483 to Daiichi Sankyo, Inc. on 2014-09-09 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Daiichi Sankyo, Inc. · Basking Ridge, United States · Issued September 9, 2014

Overview

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

Inspectional observations

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

9 Sep 2014
21 CFR 312.50

General responsibilities of sponsors

Cited by Jonee J Mearns

Inspected site

DSDaiichi Sankyo, Inc.Basking Ridge, United States

Inspection team

JJJonee J Mearns

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 1 observation

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