Kimberly Lewandowski-Walker

FDA Investigator Report

Designation: Regulatory Officer

Duty Station: Wauwatosa WI 53226

Organizations: DHHS FDA CDRH OMPT CDRH OC DICO

Total Inspections: 91

Total 483s Issued: 70

Total Warning Letters Issued: 2

Inspection Details

Longest Inspection: 36 days

Shortest Inspection: 1 days

Average Length of Inspection: 2.7 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2017-11-02RAUMEDIC - MUENCHBERGHelmbrechtsGermany3006946348
2017-04-13Zevex Incorporated (dba Moog Medical Medical Devices Group)Salt Lake CityUnited States1000117172
2017-03-23Oscor, Inc.Palm HarborUnited States1035166
2016-10-27Medtronic Vascular Galway DBA Medtronic IrelandGalwayIreland3002806434
2016-04-14Roche Diagnostics GmbHMannheimGermany3002806559
2016-03-22PUREGRAFT LLCSolana BeachUnited States3011277972
2016-02-11Astute Medical, Inc.San DiegoUnited States3009834061
2015-12-04Medtronic International Trading SarlTolochenazSwitzerland3002807576
2015-11-17Zimmer Manufacturing B.V.MerceditaUnited States1000132037
2015-09-02IOS Technologies IncSan DiegoUnited States3006594856

Co-Inspectors

NameInspectionsLast Inspection
Iris C Macinnes32014
Charles M Spyr32010
Gary D Urbiel Goldner32010
Jeffrey R Wooley22012
Sherri N Rohlf22010
Martha Sullivan Myrick22009
Christine I Shaw12017
Matthew M Vernon12017
Kathleen S Tormey12017
Stanley B Eugene12017
Lisa A Warner12017
Laiza V Garcia12015
Dawn M Braswell12015
Adaliz Santaliz-Cruz12015
Lauren E Skokan12014
Casey L Hamblin12014
Lauren E Skokan Priest12014
Thomas A Peter12014
Sargum C Sood12014
Pablo Feliciano12014
Jocelyn C Turner12014
Jesse A Vazquez12013
Linda S Shook12011
Marilyn Santiago12011
Alla Dubrovsky12011
John M Seale12011
Margaret Torres-Vazquez12011
Nicole S Williams12011
Ryan J Benedict12010
Deborah M Trout12010
Christine M Parmentier12009
Timothy C Grome12009
Karen E Masley-Joseph12008
Joseph A Morkunas12008
James W Plucinski12008

Active Locations

Year-wise Inspection Count