FDA-Inspected Site

Heart Sync, Inc.

4 FDA inspections are on record for Heart Sync, Inc. in Ann Arbor, United States.

Clean· No action indicated

Ann Arbor, United States · Last updated July 9, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-01-26.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Jan 2018 – 26 Jan 2018Medical Devices & Rad HealthClean
1 Dec 2014 – 5 Dec 2014Medical Devices & Rad HealthClean
2 May 2013 – 22 Aug 2013Medical Devices & Rad Health483On file
16 Dec 2010Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Heart Sync, Inc.'s 2 Form 483s

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