Atlas

Form 483

Ultragenyx Pharmaceutical Inc. Form 483, 2017-06-20

FDA issued a Form 483 to Ultragenyx Pharmaceutical Inc. on 2017-06-20 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Ultragenyx Pharmaceutical Inc. · Novato, United States · Issued June 20, 2017

Overview

  • 2 public-safe observations are 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.

20 Jun 2017
21 CFR 312.50

Ensuring compliance with plan and protocol

Cited by Thea C Grome

20 Jun 2017
21 CFR 312.50

General responsibilities of sponsors

Cited by Thea C Grome

Inspected site

UPUltragenyx Pharmaceutical Inc.Novato, United States

Inspection team

TCThea C Grome

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations2x

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