FDA Person
Office of the CommissionerKaren L. Kosar
View detailed information about Karen L. Kosar, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 47 inspections of 46 companies, 2016–2019.
Inspections (47)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| September 10, 2019 | Sarah D. Atkinson, M.D. | NAI | Bioresearch Monitoring | #1102583 |
| August 22, 2019 | XGen Pharmaceuticals DJB, Inc. | VAI | Bioresearch Monitoring | #1100288 |
| June 21, 2019 | Richard W. Foltin, Ph.D. | VAI | Bioresearch Monitoring | #1093938 |
| May 29, 2019 | University Of Rochester Research Subject Review Board | NAI | Bioresearch Monitoring | #1094869 |
| May 9, 2019 | Sonya Noor, M.D. | NAI | Bioresearch Monitoring | #1092724 |
| April 11, 2019 | Jerome Stevens Pharmaceuticals, Inc. | VAI | Postmarket Surv. and Epidemiology | #1086248 |
| March 21, 2019 | Meghna Trivedi, M.D. | NAI | Bioresearch Monitoring | #1086607 |
| March 8, 2019 | Marc Miller, M.D. | VAI | Project Evaluation: Devices | #1082095 |
| March 7, 2019 | Vivek Reddy, M.D. | VAI | Project Evaluation: Devices | #1081723 |
| February 13, 2019 | Kenneth Snyder, M.D. | NAI | Bioresearch Monitoring | #1080165 |
| January 17, 2019 | Was Mansoor, M.D. | NAI | Bioresearch Monitoring | #1080975 |
| January 10, 2019 | Hendrik-Tobias Arkenau | NAI | Bioresearch Monitoring | #1078705 |
| November 29, 2018 | Impulse Dynamics, Inc. | NAI | Bioresearch Monitoring | #1076124 |
| November 7, 2018 | Ascent Pharmaceuticals Inc | NAI | Bioresearch Monitoring | #1074882 |
| October 18, 2018 | Rochester Clinical Research | NAI | Bioresearch Monitoring | #1071557 |
| October 3, 2018 | Louis Aronne, M.D. | NAI | Bioresearch Monitoring | #1069647 |
| September 7, 2018 | Kevin Kalinsky, M.D. | NAI | Bioresearch Monitoring | #1065995 |
| July 10, 2018 | Amneal Pharmaceuticals Inc. | NAI | Bioresearch Monitoring | #1065634 |
| June 21, 2018 | Mesoblast, Inc. | NAI | Bioresearch Monitoring | #1058703 |
| June 5, 2018 | Eunice Wang, M.D. | NAI | Bioresearch Monitoring | #1055849 |
Documents (17)
- 483 · Pine Pharmacy and Home Care Products Center, Inc. · July 19, 2013
- 483 · Pine Pharmacy and Home Care Products Center, Inc. · April 18, 2016
- 483 · Pine Pharmacy and Home Care Products Center, Inc. · December 16, 2013
- EIR · ICON Laboratory Services, Inc. · November 22, 2019
- EIR · BASF SE · July 30, 2013
- EIR · Intrinsic Therapeutics, Inc. · March 31, 2017
- 483 · Genovefa A Papanicolaou, MD · January 27, 2021
- 483 · Richard W. Foltin, Ph.D. · June 21, 2019
- EIR · Athenex, Inc. · September 17, 2020
- EIR · ICON Laboratory Services, Inc. · June 26, 2015
- 483 · Jerome Stevens Pharmaceuticals, Inc. · April 11, 2019
- 483 · XGen Pharmaceuticals DJB, Inc. · August 22, 2019
- 483 · Marc Miller, M.D. · March 8, 2019
- EIR · Eunice Wang, M.D. · June 5, 2018
- EIR · BioTel Research, LLC · October 3, 2019
- EIR · Ascent Pharmaceuticals Inc · November 7, 2018
- EIR · ICON Laboratory Services, Inc. · July 22, 2016
Frequently inspected with (10)
Benton M. Ketron
investigator
2 shared
Johnna L. Bleem
2 shared
Omadevi Somai
2 shared
Tara K. Carmody
2 shared
Diane E. Bruce
1 shared
Janete F. Guardia
1 shared
Joanne M. Schlossin
1 shared
Joy P. Matthias
1 shared
Michelle C Roberts
1 shared
Nima Ossareh
1 shared
Related Office
Person Information
Name
Karen L. Kosar
Title
Investigator
Role
Regulatory Personnel
ID: 6e58be60-f8e3-44f3-8218-8acdde249724
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