James R Fleckenstein - FDA Investigator Report
Overview Statistics
212
Total Inspections
31
Total 483s Issued
3
Warning Letters Issued
Inspection Details
Longest Inspection: 25 days
Shortest Inspection: 1 days
Average Length: 1.5 days
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Schedule a DemoJames R Fleckenstein's Recent Inspections
| Date | Company | City | Country | FEI Number | 483 |
|---|---|---|---|---|---|
| 2016-09-14 | Stroma Medical Corporation | Irvine | United States | 3009353393 | |
| 2016-09-13 | Focal Therapeutics | Aliso Viejo | United States | 3011179400 | |
| 2016-08-25 | Trimedyne Inc | Irvine | United States | 1419951 | |
| 2016-07-27 | Andwin Scientific | Simi Valley | United States | 2027344 | |
| 2016-07-14 | R & D Medical Products, Inc. | Lake Forest | United States | 3001236548 | |
| 2016-06-28 | INTEGRATED ENDOSCOPY, INC. | Irvine | United States | 3011401113 | |
| 2016-05-27 | Invacare Rehabilitation Equipment Co., Ltd | Suzhou | China | 3008262382 | |
| 2016-05-25 | SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO., LTD. | Suzhou | China | 3007123930 | |
| 2016-05-19 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | Hangzhou | China | 3008729910 | |
| 2016-04-27 | Eagle Medical Inc | Paso Robles | United States | 1000125025 |
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Download 483s and EIRs for James R FleckensteinJames R Fleckenstein - Co-Inspectors
| Name | Inspections | Last Inspection |
|---|---|---|
| Greg K Keshishyan | 7 | 2013 |
| Uttaniti Limchumroon | 4 | 2015 |
| Sarah A Hassas | 3 | 2016 |
| Kelvin Cheung | 3 | 2015 |
| Jennifer M Gogley | 3 | 2013 |
| Juanita Banuelos | 2 | 2014 |
| Jocelyn E Massey | 2 | 2013 |
| John R Myung | 2 | 2013 |
| Sonya L Karsik | 2 | 2013 |
| Wendy R Blame | 2 | 2012 |
| Charles L Larson | 2 | 2011 |
| Rebecca T Davis | 2 | 2008 |
| Doan T Nguyen | 1 | 2014 |
| Shaquenta Y Perkins | 1 | 2014 |
| Eileen T Dupont | 1 | 2014 |
| Dejon N Harris | 1 | 2013 |
| Diane C Van Leeuwen | 1 | 2012 |
| Shannon B Ruelle | 1 | 2011 |
| Trudy R Papson | 1 | 2011 |
| Rocio Guzman-Velazquez | 1 | 2011 |
| Allen F Hall | 1 | 2010 |
| Truong X Nguyen | 1 | 2010 |
| Tania Y Hall | 1 | 2010 |
| Yvette E Guillermo | 1 | 2009 |
| Donna L Besone | 1 | 2009 |
| Troy D Mansell | 1 | 2008 |
| Joan A Loreng | 1 | 2008 |
| Norman Wong | 1 | 2008 |
| Leonard H Lavi | 1 | 2008 |
James R Fleckenstein's Active Locations
- United States
- China
- India
- Ukraine
- Bulgaria
- Canada
- Germany
- Singapore
- Italy
- Romania
- South Africa
- Japan
- Netherlands
- Russia
James R Fleckenstein's Year-wise Inspection Count
- 2008:24 inspections
- 2009:21 inspections
- 2010:22 inspections
- 2011:25 inspections
- 2012:26 inspections
- 2013:24 inspections
- 2014:26 inspections
- 2015:26 inspections
- 2016:18 inspections
Last Updated: 2025-05-14 06:11:22