FDA-Inspected Site

Roche Molecular Systems, Inc.

9 FDA inspections are on record for Roche Molecular Systems, Inc. in Pleasanton, United States.

Clean· No action indicated

Pleasanton, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 0 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-11-30.

At a glance

Inspections

9

Form 483s

0

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Nov 2023 – 30 Nov 2023Medical Devices & Rad HealthClean
22 Feb 2017 – 27 Feb 2017Medical Devices & Rad HealthClean
29 Aug 2016 – 1 Sep 2016Medical Devices & Rad HealthClean
28 Mar 2016 – 30 Mar 2016Medical Devices & Rad HealthClean
14 May 2014 – 20 May 2014Medical Devices & Rad HealthClean
21 May 2012Not recordedClean
14 Mar 2012Not recordedClean
1 Mar 2011Not recordedClean
24 Feb 2009Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Roche Molecular Systems, Inc.'s inspection record

The full inspection record, as Atlas holds it, 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