FDA-Inspected Site

Zimmer, Inc.

13 FDA inspections are on record for Zimmer, Inc. in Warsaw, United States.

Clean· No action indicated

Warsaw, United States · Last updated July 9, 2026

Overview

  • 13 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-09.

At a glance

Inspections

13

Form 483s

7

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Feb 2026 – 9 Feb 2026Medical Devices & Rad HealthClean
18 Jul 2022 – 27 Jul 2022Medical Devices & Rad HealthClean
2 Oct 2017 – 16 Oct 2017Medical Devices & Rad Health483View 483 →
19 Oct 2015 – 20 Nov 2015Medical Devices & Rad Health483View 483 →
21 Apr 2014 – 28 May 2014Medical Devices & Rad Health483View 483 →
3 Feb 2014 – 7 Feb 2014Medical Devices & Rad Health483View 483 →
13 Aug 2013 – 19 Aug 2013Medical Devices & Rad HealthClean
6 May 2013 – 20 Jun 2013Medical Devices & Rad Health483View 483 →
21 May 2012Not recorded483View 483 →
22 Jul 2011Not recorded483View 483 →
19 Mar 2009Not recordedClean
5 Sep 2007Not recordedClean

Observations on record

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

16 Oct 2017
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Rosanna M Goodrich, Joseph R Strelnik, Suyang Qin

16 Oct 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Rosanna M Goodrich, Joseph R Strelnik, Suyang Qin

16 Oct 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Rosanna M Goodrich, Joseph R Strelnik, Suyang Qin

16 Oct 2017
21 CFR 820.130

Packaging

Cited by Rosanna M Goodrich, Joseph R Strelnik, Suyang Qin

16 Oct 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Rosanna M Goodrich, Joseph R Strelnik, Suyang Qin

Investigators

FDA investigators tied to this site in the record.

Suyang Qin3 insp.
Brian M Campbell2 insp.
Brian M Marosan1 insp.
Calvin K Cook1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations8x
21 CFR 820.130Cited across public-safe Form 483 observations6x
21 CFR 820.90(a)Cited across public-safe Form 483 observations6x
21 CFR 820.30(g)Cited across public-safe Form 483 observations5x
21 CFR 820.72(a)Cited across public-safe Form 483 observations5x
21 CFR 820.75(a)Cited across public-safe Form 483 observations5x
21 CFR 820.198(a)Cited across public-safe Form 483 observations4x
21 CFR 820.30(d)Cited across public-safe Form 483 observations4x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 820.250(b)Cited across public-safe Form 483 observations3x
21 CFR 820.75(b)Cited across public-safe Form 483 observations3x
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.70(i)Cited across public-safe Form 483 observations2x
21 CFR 820.72(b)Cited across public-safe Form 483 observations2x
21 CFR 820.80(b)Cited across public-safe Form 483 observations2x
21 CFR 50.25(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 812.46(a)Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(e)Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.80(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Zimmer, Inc.'s 7 Form 483s

Source PDFs, 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