FDA-Inspected Site

Ultragenyx Pharmaceutical Inc.

3 FDA inspections are on record for Ultragenyx Pharmaceutical Inc. in Novato, United States.

Clean· No action indicated

Novato, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-07-17.

At a glance

Inspections

3

Form 483s

1

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jul 2025 – 17 Jul 2025Human DrugsClean
22 Feb 2023 – 27 Feb 2023Human DrugsClean
13 Jun 2017 – 20 Jun 2017Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

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

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

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

Full site report

Get the verbatim findings behind Ultragenyx Pharmaceutical Inc.'s 1 Form 483

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat