Atlas

Form 483

3SHAPE TRIOS Form 483, 2017-06-30

FDA issued a Form 483 to 3SHAPE TRIOS on 2017-06-30 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

3SHAPE TRIOS · Copenhagen K, Denmark · Issued June 30, 2017

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 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.

30 Jun 2017
21 CFR 820.30(b)

Design plans- updated

Cited by Donna L Besone

30 Jun 2017
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Donna L Besone

30 Jun 2017
21 CFR 820.30(g)

Design validation - production units

Cited by Donna L Besone

30 Jun 2017
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Donna L Besone

Inspected site

3T3SHAPE TRIOSCopenhagen K, Denmark

Inspection team

DLDonna L Besone

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.30(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

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