Atlas

FDA-Inspected Site

3shape Poland Sp. Z o.o

2 FDA inspections are on record for 3shape Poland Sp. Z o.o in Szczecin, Poland.

483· Form 483 issued

Szczecin, Poland · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2017-06-30.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Jun 2017 – 30 Jun 2017Medical Devices & Rad Health483On file
23 Sep 2013 – 26 Sep 2013Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

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

Supplier oversight

Cited by Roy Baby

Investigators

FDA investigators tied to this site in the record.

Donna L Besone1 insp.
Roy Baby1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind 3shape Poland Sp. Z o.o's 2 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat