Dorothy W Lee

FDA Investigator Report

Designation: SUPERVISORY CONSUMER SAFETY

Duty Station: Rockville MD 20857

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO

Total Inspections: 18

Total 483s Issued: 17

Total Warning Letters Issued: 6

Inspection Details

Longest Inspection: 5 days

Shortest Inspection: 2 days

Average Length of Inspection: 1.6 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2015-03-31Cepheid AbSolnaSweden3009613136
2015-03-26Bioprod D.O.O.LjubljanaSlovenia3010084488
2014-04-10DiaSorin Ireland Ltd.DublinIreland3002806536
2014-03-31Medinol Ltd.Tel AvivIsrael3003084171
2014-03-27Medinol Ltd.JerusalemIsrael3003182398
2014-02-20Creganna Medical Pte LtdSingaporeSingapore3008950987
2014-02-12I-Sens, Inc.SeoulKorea (the Republic of)3005621222
2013-04-23VARITEKS ORTOPEDI SAN. A.S.ZeytinburnuTurkey3009303371
2013-04-17Vision RT LtdLondonUnited Kingdom3004832819
2013-01-30Catalent Belgium SABrusselsBelgium3007647000

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Download 483s and EIRs for Dorothy W Lee

Co-Inspectors

NameInspectionsLast Inspection
Catherine J Laufmann22014
James C Maclaughlin12013
Parul M Patel12013

Active Locations

Year-wise Inspection Count