James W Plucinski

FDA Investigator Report

Total Inspections: 118

Total 483s Issued: 64

Total Warning Letters Issued: 9

Inspection Details

Longest Inspection: 5 days

Shortest Inspection: 1 days

Average Length of Inspection: 1.2 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2014-11-19Biocer Entwicklungs, GMBHBayreuthGermany3009749957
2014-11-13GMS Gesellschaft f.medizinische SondentechnikMielkendorfGermany3002807094
2014-11-06Unitron Group BvIjzendijkeNetherlands3008388260
2014-11-06CD Leycom B.V.HengeloNetherlands3003493679
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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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

Active Locations

Year-wise Inspection Count