Atlas

FDA-Inspected Site

ESI, Inc.

5 FDA inspections are on record for ESI, Inc. in Plymouth, United States.

483· Form 483 issued

Plymouth, United States · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-03-26.

At a glance

Inspections

5

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Mar 2026 – 26 Mar 2026Medical Devices & Rad Health483View 483 →
17 May 2019Medical Devices & Rad HealthClean
11 Aug 2015Medical Devices & Rad HealthClean
6 Jul 2012Not recordedClean
10 Jul 2008Not recordedClean

Observations on record

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

26 Mar 2026
ISO 13485:2016 Clause 4.2.3

Medical device file does not contain specific requirements

Cited by Tyler R Courtney

26 Mar 2026
ISO 13485:2016 Clause 4.2.4

Lack of document control

Cited by Tyler R Courtney

26 Mar 2026
ISO 13485:2016 Clause 6.1(a)

Resources for quality management system have not been determined or provided

Cited by Tyler R Courtney

26 Mar 2026
ISO 13485:2016 Clause 6.2

Process(es) for personnel competence, training and awareness not documented

Cited by Tyler R Courtney

26 Mar 2026
ISO 13485:2016 Clause 6.4.1

Work environment requirements and procedures not documented

Cited by Tyler R Courtney

Investigators

FDA investigators tied to this site in the record.

Tyler R Courtney1 insp.
Christina L Bigham1 insp.
Jennifer S Ness1 insp.
James A Beaulieu1 insp.
Kellie L Westerbuhr1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.2.3Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.2.4Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.1(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.3Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.4Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ESI, Inc.'s 1 Form 483

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