Atlas

FDA-Inspected Site

Shent USA, Inc.

6 FDA inspections are on record for Shent USA, Inc. in Northborough, United States.

483· Form 483 issued

Northborough, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-07-02.

At a glance

Inspections

6

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jul 2026 – 2 Jul 2026Medical Devices & Rad Health483View 483 →
6 Jun 2023 – 9 Jun 2023Medical Devices & Rad HealthClean
22 Feb 2018 – 23 Feb 2018Medical Devices & Rad Health483View 483 →
23 Sep 2014 – 30 Sep 2014Medical Devices & Rad Health483View 483 →
24 Aug 2011Not recorded483View 483 →
14 Mar 2005Not recordedClean

Observations on record

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

2 Jul 2026
ISO 13485:2016 Clause 7.3.4

Design and development outputs not adequate

Cited by Jeffrey J Thibodeau

2 Jul 2026
ISO 13485:2016 Clause 7.3.4

Design and development outputs not adequate

Cited by Jeffrey J Thibodeau

23 Feb 2018
21 CFR 820.90(a)

Nonconforming product control

Cited by Abby E Pelletier

30 Sep 2014
21 CFR 820.40

Lack of procedures, or not maintained

Cited by Jonathan B Lewis

30 Sep 2014
21 CFR 820.90(b)(2)

Product rework procedures, Lack of or inadequate procedures

Cited by Jonathan B Lewis

Investigators

FDA investigators tied to this site in the record.

Jeffrey J Thibodeau1 insp.
Eric C Schmitt1 insp.
Abby E Pelletier1 insp.
Jonathan B Lewis1 insp.
Justine M Corson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 7.3.4Cited across public-safe Form 483 observations2x
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.90(b)(1)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Shent USA, Inc.'s 4 Form 483s

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