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Form 483

Shent USA, Inc. Form 483, 2026-07-02

FDA issued a Form 483 to Shent USA, Inc. on 2026-07-02 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Shent USA, Inc. · Northborough, United States · Issued July 2, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

SUShent USA, Inc.Northborough, United States

Inspection team

JJJeffrey J Thibodeau

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.3.4Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere