James R Fleckenstein

FDA Investigator Report

Total Inspections: 212

Total 483s Issued: 31

Total Warning Letters Issued: 2

Inspection Details

Longest Inspection: 25 days

Shortest Inspection: 1 days

Average Length of Inspection: 1.5 days

Discover the bigger picture. This is just the tip of the iceberg.

Gain access to comprehensive analysis, detailed reports, AI assistant, and much more.

Schedule a Demo

Recent Inspections

DateCompanyCityCountryFEI Number483
2016-09-14Stroma Medical CorporationIrvineUnited States3009353393
2016-09-13Focal TherapeuticsAliso ViejoUnited States3011179400
2016-08-25Trimedyne IncIrvineUnited States1419951
2016-07-27Andwin ScientificSimi ValleyUnited States2027344
2016-07-14R & D Medical Products, Inc.Lake ForestUnited States3001236548
2016-06-28INTEGRATED ENDOSCOPY, INC.IrvineUnited States3011401113
2016-05-27Invacare Rehabilitation Equipment Co., LtdSuzhouChina3008262382
2016-05-25SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO., LTD.SuzhouChina3007123930
2016-05-19HANGZHOU BEVER MEDICAL DEVICES CO., LTD.HangzhouChina3008729910
2016-04-27Eagle Medical IncPaso RoblesUnited States1000125025

Sign Up to get the complete report.

Download 483s and EIRs for James R Fleckenstein

Co-Inspectors

NameInspectionsLast Inspection
Greg K Keshishyan72013
Uttaniti Limchumroon42015
Sarah A Hassas32016
Kelvin Cheung32015
Jennifer M Gogley32013
Juanita Banuelos22014
Jocelyn E Massey22013
John R Myung22013
Sonya L Karsik22013
Wendy R Blame22012
Charles L Larson22011
Rebecca T Davis22008
Doan T Nguyen12014
Shaquenta Y Perkins12014
Eileen T Dupont12014
Dejon N Harris12013
Diane C Van Leeuwen12012
Shannon B Ruelle12011
Trudy R Papson12011
Rocio Guzman-Velazquez12011
Allen F Hall12010
Truong X Nguyen12010
Tania Y Hall12010
Yvette E Guillermo12009
Donna L Besone12009
Troy D Mansell12008
Joan A Loreng12008
Norman Wong12008
Leonard H Lavi12008

Active Locations

Year-wise Inspection Count