FDA-Inspected Site

Teva Operations Poland sp. z.o.o.

4 FDA inspections are on record for Teva Operations Poland sp. z.o.o. in Krakow, Poland.

483· Form 483 issued

Krakow, Poland · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2014-03-28.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Mar 2014 – 28 Mar 2014Human Drugs483On file
8 Dec 2011Not recordedClean
17 Jul 2008Not recorded483On file
13 May 2005Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Mark R Mcclain1 insp.

Full site report

Get the verbatim findings behind Teva Operations Poland sp. z.o.o.'s 2 Form 483s

The full inspection record, as Atlas holds it, 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