Atlas

Form 483

Shent USA, Inc. Form 483, 2018-02-23

FDA issued a Form 483 to Shent USA, Inc. on 2018-02-23 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Shent USA, Inc. · Northborough, United States · Issued February 23, 2018

Overview

  • 1 public-safe observation is 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.

23 Feb 2018
21 CFR 820.90(a)

Nonconforming product control

Cited by Abby E Pelletier

Inspected site

SUShent USA, Inc.Northborough, United States

Inspection team

AEAbby E Pelletier

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

Every observation in full, 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