Atlas

Form 483

3shape Poland Sp. Z o.o Form 483, 2013-09-26

FDA issued a Form 483 to 3shape Poland Sp. Z o.o on 2013-09-26 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

3shape Poland Sp. Z o.o · Szczecin, Poland · Issued September 26, 2013

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.

26 Sep 2013
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Roy Baby

Inspected site

3P3shape Poland Sp. Z o.oSzczecin, Poland

Inspection team

RBRoy Baby

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.50(a)(2)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