Atlas

FDA-Inspected Site

Synthes, Inc.

8 FDA inspections are on record for Synthes, Inc. in West Chester, United States.

483· Form 483 issued

West Chester, United States · Last updated July 11, 2026

Overview

  • 8 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2013-11-13.

At a glance

Inspections

8

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Nov 2013 – 13 Nov 2013Medical Devices & Rad Health483View 483 →
13 May 2013 – 16 May 2013Medical Devices & Rad HealthClean
19 Oct 2012Not recorded483View 483 →
15 Sep 2011Not recorded483View 483 →
8 Oct 2009Not recordedClean
27 Apr 2009Not recorded483On file
10 Aug 2007Not recordedClean
14 Jun 2005Not recordedClean

Observations on record

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

13 Nov 2013
21 CFR 820.100(b)

Documentation

Cited by Joseph L Despins, Thomas E Friel, Julianne C Mccullough

19 Oct 2012
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Thomas E Friel, Phillip M Pontikos

15 Sep 2011
21 CFR 803.17(a)(3)

Lack of System for Timely Submission of Reports

Cited by Joseph L Despins

15 Sep 2011
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Joseph L Despins

15 Sep 2011
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Joseph L Despins

Investigators

FDA investigators tied to this site in the record.

Joseph L Despins3 insp.
Thomas E Friel2 insp.
Michael J Nerz2 insp.
Julianne C Mccullough1 insp.
Phillip M Pontikos1 insp.
Judith A Paterson1 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 observations2x
21 CFR 803.17(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 803.50(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 803.52(f)(6)Cited across public-safe Form 483 observations1x
21 CFR 803.56Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(d)Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Synthes, Inc.'s 4 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