Atlas

FDA-Inspected Site

Abbott

14 FDA inspections are on record for Abbott in Plymouth, United States.

483· Form 483 issued

Plymouth, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-06-28.

At a glance

Inspections

14

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Jun 2024 – 28 Jun 2024Medical Devices & Rad Health483View 483 →
6 Jan 2020 – 10 Jan 2020Medical Devices & Rad HealthClean
19 Jun 2018 – 22 Jun 2018Medical Devices & Rad HealthClean
26 Apr 2018Medical Devices & Rad HealthClean
23 Apr 2018 – 25 Apr 2018Medical Devices & Rad HealthClean
10 Jan 2018 – 1 Feb 2018Medical Devices & Rad HealthClean
15 May 2017 – 19 May 2017Medical Devices & Rad HealthClean
14 Sep 2016 – 16 Sep 2016Medical Devices & Rad HealthClean
27 Oct 2014 – 30 Oct 2014Medical Devices & Rad HealthClean
11 Jun 2013Medical Devices & Rad HealthClean
28 Feb 2013 – 8 Mar 2013Medical Devices & Rad Health483On file
5 Oct 2011Not recordedClean

Observations on record

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

28 Jun 2024
21 CFR 812.40

Sponsors' general responsibilities

Cited by Sharon L Matson

28 Jun 2024
21 CFR 812.46(a)

Device return/disposal by non-compliant investigator

Cited by Sharon L Matson

28 Jun 2024
21 CFR 812.46(a)

Sponsor securing investigator compliance

Cited by Sharon L Matson

Investigators

FDA investigators tied to this site in the record.

Sharon L Matson4 insp.
MDSAP harperd2 insp.
Ralph W Jerndal2 insp.
Benjamin W Anderson2 insp.
Marissa S Steinhagen2 insp.
MDSAP WilliamsA1 insp.
Jennifer S Ness1 insp.
Aaron L Dunbar1 insp.
Aimee J Edwin1 insp.
James A Beaulieu1 insp.
Jessica L Johnson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 812.46(a)Cited across public-safe Form 483 observations2x
21 CFR 812.40Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Abbott's 2 Form 483s

Source PDFs 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