FDA Investigator Karen M Kondas
Karen M Kondas has conducted inspections on 328 sites in 2 countries as of 17 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
328
Last Inspection Date:
17 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
Canada
FDA Investigators that have inspected at least one site in common with Karen M Kondas:
Aaron J Fox,
Allen F Hall,
Allison E Sincek,
Amy L Mccarthy,
Andrew J Barrowcliff,
Andrew J Lang,
Andria L Kuhlman,
Angela E Glenn,
Annemarie H Cochran,
Annemarie Kleiza,
Barbara G Peoples,
Barbara M Frazier,
Benjamin J Dastoli,
Benjamin P Stewart,
Brian D Rogers,
Brittany M Kershaw,
Brunilda Torres,
Bryce A Hammer,
Carl J Montgomery,
Carol Rivera Lopez, PhD,
Cassandra L Winters,
Charles C Conn, III,
Chiaochun J Wang,
Christina D Mello,
Christine M Whitby, CSO,
Christopher D Snyder,
Christopher T Middendorf,
Clinton D Priestley,
Craig T Rybus,
Cynthia L Rakestraw,
D'arbra R Blankenship,
Daniel J Mechenbier,
Darla J Christopher,
Darren S Morgan,
Deborah M Trout,
Dell S Moller,
Denise D Dion,
Diane M Fresch,
Djamila Harouaka,
Donna D Gallien, MPH,
Dorathy M Eischen,
Dr. Abhijit Raha, PhD,
Dr. Gopa Biswas, PhD,
Dr. Mark J Seaton, PhD,
Dr. Sriram Subramaniam, PhD,
Dr. Zhou Chen (nmi), MD PhD,
Edward R Kay,
Elizabeth Ll Edwards,
Emilie E Kahn,
Erica L Nicoll,
Frederick M Lochner,
Gayle S Lawson,
Geoffrey K Kilili,
Hugh M Mcclure, II,
Iris C Macinnes,
Jacqueline A O'shaughnessy, PhD,
James E Frye,
James R Evans,
Janet L Bowen,
Jazmine N Still,
Jeffrey A Sincek,
Jennifer A Downie,
Jennifer A Longie Vollom,
Jennifer A Pruden,
Jennifer L Gustavus,
Jennifer L Jager,
Jennifer L Sheehan,
Jennifer M Heitz,
Joel D Martinez,
John A Kadavil, PhD,
Joshua P Wireman,
Joshua S Hunt,
Julie D Bringger,
Karen M Cooper,
Kathleen D Culver,
Kathryn J Mccarty,
Kathryn Suttling,
Kelli L Wilkinson,
Kent A Conforti,
Larry K Austin,
Laureen M Geniusz,
Lauren N Howard,
Lauren N Smith,
Li Hongpaul Yeh, PhD,
Lisa L Flores,
Marcia A Worley,
Margaret M Annes,
Mark E Parmon,
Martin K Yau, PhD,
Mary E Storch,
Matthew B Casale,
Matthew H Pitts,
Melkamu Getie Kebtie, PhD,
Michael E Clark,
Michael I Gorman,
Michael J Schibi,
Michael P Sheehan,
Mishelle L Harriger,
Nancy L Neiger,
Nibin Varghese, MS,
Nicholas L Paulin,
Nicola M Fenty Stewart,
Nilufer M Tampal, PhD,
Nisha C Patel,
Paul A Bonneau,
Paul E Stein,
Paula A Trost,
Paula M Laplant,
Phillip M Pontikos,
Pifer,
Ralph A Erickson,
Regina T Brown,
Richard W Berning,
Robert C Steyert,
Robert Jennings,
Rose Ashley,
Shankar L Saha,
Shannon F Underwood,
Sneha S Patel,
Sripal R Mada, PhD,
Stephen J Kilker,
Stephen J Rabe,
Susan D Yuscius,
Susanne M Richardson, MS RAC,
Tamara M Kays,
Ted L Anderson,
Thomas J Arista,
Thomas W Nojek,
Thunder N Dunkijacobs,
Travis M Beard,
Travis R Hunt,
Tyra S Wisecup,
Ucheabuchi Cchudi Nwankwor,
Vipulchandra N Dholakia,
Wen Ning Chan (Sally),
Yiyue Zhang (nmi), PhD,
Yvette Mlacour Davis,
Zhigang Sun, PhD
Karen M Kondas's Documents
Experience Redica Systems’ NEW investigator profiles and dashboards
Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:
- Total inspections conducted
- 483 rate
- OAI rate
- Warning Letter rate
- Inspections by Industry, Scope, and Inspection Reason
- And much more
Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.
![FDA Investigator Profile Icon](https://redica.com/document-store/images/InspectorProfile.png)
Talk to sales to access our investigator profiles
Loading...
Investigator Profiles Are Just the Tip of the Iceberg
Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:
Inspection Intelligence
- Pre-Approval Inspection (PAI) trends
- The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
- Latest 483s: see what the trends are across all FDA Investigators
- CFR Heatmap: Citations aggregated by Subpart by Year
Vendor Intelligence
- Full inspection histories for your vendors down to the specific site level
- All of the functionality mentioned above but isolated to just your vendors
Regulatory Intelligence
- Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
- All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more