James W Plucinski - FDA Investigator Report

Overview Statistics

118
Total Inspections
64
Total 483s Issued
9
Warning Letters Issued

Inspection Details

Longest Inspection: 5 days
Shortest Inspection: 1 days
Average Length: 1.2 days

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James W Plucinski's Recent Inspections

DateCompanyCityCountryFEI Number483
2014-11-19Biocer Entwicklungs, GMBHBayreuthGermany3009749957
2014-11-13GMS Gesellschaft f.medizinische SondentechnikMielkendorfGermany3002807094
2014-11-06CD Leycom B.V.HengeloNetherlands3003493679
2014-11-06Unitron Group BvIjzendijkeNetherlands3008388260
2014-09-11SMITH & NEPHEW ORTHOPEDICS (BEIJING) CO., LTD.BeijingChina3008892118
2014-09-05NanoEnTek FactorySuwon, Korea (the Republic of)3007349751
2014-09-05Nanoentek IncSeoulKorea (the Republic of)3009092698
2014-08-28Nuga Medical Co., Ltd.WonjuKorea (the Republic of)3004006265
2014-07-17MARVAO MEDICAL DEVICES LTD.GalwayIreland3008110587
2014-07-10Resmed Germany IncMartinsriedmartinsriedGermany3007205734

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James W Plucinski - Co-Inspectors

NameInspectionsLast Inspection
Stefen D Mcmillan72012
Amanda S Zorn52012
Joseph A Morkunas42010
Andrew A Leboeuf22012
Brian D Nicholson22012
Zerita Bomani22011
Jeanne J Chiu22011
Lauren A Crivellone22011
Margaret Torres-Vazquez22011
Joshua M Adams22011
Kathleen S Tormey22011
Carrie-Ann Plucinski22009
Karen E Masley-Joseph22008
Sean T Creighton12012
Susan W Ciani12011
Tara C Alcazar12011
Nicholas P Diorio12011
Marcia A Worley12011
Brian P Emanuel12011
Patrick E Gainer12011
Paola S Barnett12010
Nicole S Williams12010
Denarvis C Mendenhall12009
Sarah B Tanksley12009
Martha T Olone12009
Rafael Padilla12009
Ashley L Reiber12009
Debra I Love12009
Kimberly Lewandowski-Walker12008
Christina A Miller12008

James W Plucinski's Active Locations

  • United States
  • Germany
  • China
  • India
  • Netherlands
  • Korea (the Republic of)
  • Sweden
  • Japan
  • United Kingdom
  • Ireland
  • Dominican Republic (the)
  • Taiwan
  • France
  • Switzerland
  • Austria
  • Malaysia
  • Norway
  • Singapore
  • Spain

James W Plucinski's Year-wise Inspection Count

  • 2008:9 inspections
  • 2009:17 inspections
  • 2010:14 inspections
  • 2011:28 inspections
  • 2012:13 inspections
  • 2013:16 inspections
  • 2014:21 inspections
Last Updated: 2025-05-14 06:11:22