Karen M Rodriguez

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Miami FL 33014-2048

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO DMDRHOII MDRHIB

Total Inspections: 199

Total 483s Issued: 170

Total Warning Letters Issued: 12

Inspection Details

Longest Inspection: 113 days

Shortest Inspection: 1 days

Average Length of Inspection: 6.0 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2023-10-18J&T Health and Wellness LLCSaint PetersburgUnited States1000525872
2023-09-26Exactech, Inc.GainesvilleUnited States1038671
2023-08-17Myriad Medical, LLCTampaUnited States3008513105
2023-08-11Ultra Clean Systems, Inc.OldsmarUnited States3002811406
2023-06-28Boyd Technologies (Thailand) Co., Ltd.MuangThailand3014640930
2023-06-22Thai Hospital Products Co., Ltd.PakkretThailand3003024808
2023-06-15Innosys Co., Ltd.UijeongbuKorea (the Republic of)3003200961
2023-05-05Arthrex, Inc.NaplesUnited States1220246
2023-03-16Cambridge Diagnostic Products, Inc.Ft LauderdaleUnited States1029182
2023-02-17New Wave Endo-Surgical, Corp.Coconut CreekUnited States3015209038

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Co-Inspectors

NameInspectionsLast Inspection
Karen M Cruz Arenas142023
David M Wilkinson52020
James T O Neal52013
Omayra N Rodriguez-Ruiz42015
Leo J Lagrotte42013
Craig A Garmendia42013
Sean T Creighton42013
Kelly M Byers42011
Dianiris C Ayala32023
Gisselle I Sensebe32022
Nicholas T Domer32020
David E Lowe32020
Paul A Licata32015
Joanne E King32013
Leslin M Coachman32012
Ebony D Sanon22023
Angelica M Chica22015
Michael C Lombardi22014
Dawn M Mccabe22013
John J Bernal22013
Shavon L Square22012
Clara E Santiago22011
Alex J Wild12022
Brandon P Thompson12022
Stanley B Eugene12021
Jennifer L Huntington12019
Dennis R Hock12016
Eric R Holm12014
Toby L Keaton12013
Ashley A Mutawakkil12013
Sophia A Sands12012
Jennifer Caycedo12012
Beira Montalvo12012
Richard K Vogel12012
Rachel Peters12011
German Rivera12011
Teresa I Navas12011
Nicole M Bell12010

Active Locations

Year-wise Inspection Count