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Form 483

3D SYSTEMS - LAYERWISE Form 483, 2017-04-06

FDA issued a Form 483 to 3D SYSTEMS - LAYERWISE on 2017-04-06 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

3D SYSTEMS - LAYERWISE · Leuven, Belgium · Issued April 6, 2017

Overview

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

Inspectional observations

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

6 Apr 2017
21 CFR 820.198(a)

Complaints

Cited by Marc S Neubauer

6 Apr 2017
21 CFR 820.70(i)

Software validation for automated processes

Cited by Marc S Neubauer

Inspected site

3S3D SYSTEMS - LAYERWISELeuven, Belgium

Inspection team

MSMarc S Neubauer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(i)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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