FDA-Inspected Site

Exelixis, Inc.

5 FDA inspections are on record for Exelixis, Inc. in Alameda, United States.

483· Form 483 issued

Alameda, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-05.

At a glance

Inspections

5

Form 483s

3

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Apr 2026 – 5 May 2026Human Drugs483View 483 →
21 Mar 2018 – 27 Mar 2018Human DrugsClean
27 Sep 2012Not recorded483View 483 →
13 Sep 2012Not recordedClean
24 Sep 2008Not recorded483On file

Observations on record

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

5 May 2026
21 CFR 312.50

General responsibilities of sponsors

Cited by Cynthia J Tsui

27 Sep 2012
21 CFR 312.50

General responsibilities of sponsors

Cited by Aneel K Sandhu

27 Sep 2012
21 CFR 312.56(b)

Investigator non-compliance

Cited by Aneel K Sandhu

Investigators

FDA investigators tied to this site in the record.

Kevin P Foley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations2x
21 CFR 312.56(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Exelixis, Inc.'s 3 Form 483s

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