Atlas

FDA-Inspected Site

Accuray Incorporated

9 FDA inspections are on record for Accuray Incorporated in Sunnyvale, United States.

Clean· No action indicated

Sunnyvale, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2016-08-09.

At a glance

Inspections

9

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Aug 2016 – 9 Aug 2016Medical Devices & Rad HealthClean
3 Jun 2015 – 12 Jun 2015Medical Devices & Rad HealthClean
3 May 2015 – 12 May 2015Medical Devices & Rad HealthClean
3 Jul 2012Not recorded483View 483 →
10 May 2011Not recorded483View 483 →
2 Sep 2008Not recorded483On file
26 Apr 2006Not recordedClean
12 May 2004Not recordedClean
9 Mar 2001Not recordedClean

Observations on record

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

3 Jul 2012
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Christine M Parmentier

3 Jul 2012
21 CFR 820.70(a)

Process control procedures, Lack of or inadequate procedures

Cited by Christine M Parmentier

3 Jul 2012
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Christine M Parmentier

10 May 2011
21 CFR 820.25(b)

Training - Lack of or inadequate procedures

Cited by Mark E Chan

10 May 2011
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Mark E Chan

Investigators

FDA investigators tied to this site in the record.

Joseph A Seitz2 insp.
Christine M Parmentier2 insp.
Mary R Hole1 insp.
Mark E Chan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.25(b)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.200(a)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Accuray Incorporated's 3 Form 483s

Source PDFs, 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