FDA Investigator Kshitij A Patkar
Kshitij A Patkar has conducted inspections on 8 sites in 5 countries as of 20 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
8
Last Inspection Date:
20 May 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America,
China,
India,
Czechia,
Ireland
FDA Investigators that have inspected at least one site in common with Kshitij A Patkar:
Ademola O Daramola,
Alicia M Mozzachio,
Alison N Stieg,
Ana Paulap Sandee,
Anastasia I Onuorah,
Anastasia M Shields,
Andrew J Barrowcliff,
Anthony R Bucks,
Ariel Cruz Figueroa,
Arulvathani P Arudchandran,
Atul J Agrawal,
Bo Chi, PhD,
Brian D Nicholson,
Brooke K Higgins,
Brooke K Seeman,
Bruce H Mccullough,
Carl A Huffman, III,
CDR Ileana Barreto Pettit,
Chaltu Nwakijra,
Charles I Ann,
Chih Jung Hsu, PhD,
Christopher D Leach,
Darryl T Newell,
David Perkins,
Debra I Love,
Denise M Digiulio,
Dennis Cantellops Paite,
Dennis L Doupnik,
Diane T Bargo,
Diane T O'brien,
Douglas A Campbell,
Dr. Zhihao Qiu (Peter), PhD,
Eboni S Funderburk,
Edwin Martinez,
Elizabeth L Philpy,
Emest F Bizjak,
Emilio O Escobar,
Eric M Padgett,
Erika V Butler,
Erin D Mccaffery,
Francis A Guidry,
Frank Wackes,
Georgia A Layloff,
Guerlain Ulysse,
Hongjian Ding,
Jacob G Lutz,
Jai P Singh,
James I Giefer,
James M Mason,
Janet A Rajan,
Javier E Santos,
Jawaid Hamid,
Jeffrey P Raimondi,
Jing Fang,
Joel D Hustedt,
John P Mistler,
Johnna L Bleem,
Jonathan W Chapman,
Jose M Cayuela,
Joshua M Adams,
Junho Pak,
Karen C Daugherty,
Katelyn Astaub Zamperini,
Ko U Min,
Lakshmi Narasimhan, PhD,
Lareese K Thomas,
Laura Fontan, MS,
Laurie A Haxel,
Lawrence J Stringer,
Lequita M Mayhew,
Libia M Lugo,
Luis A Dasta,
Marcus A Ray,
Maria Cecilia Tami, PhD,
Maria Gutierrez Hoffman, PhD,
Marijo B Kambere, PhD,
Mark G Peterson,
Mary E Storch,
Massoud Motamed,
Melissa J Garcia,
Melissa T Roy,
Michael Shanks, MS,
Michele Gottshall,
Michele L Glendenning,
Michele Perry Williams,
Michelle Marsh,
Milos Dokmanovic, PhD,
Mra Davism,
Nancy M Espinal,
Nicholas P Diorio,
Patrick C Klotzbuecher,
Paula J Bretz,
Phung Thien Nguyen,
Pratik S Upadhyay, DDC,
Qin Xu,
Rabin N Ghoshal,
Rebecca E Dombrowski,
Rebecca Rodriguez,
Richard Ledwidge (nmi), PhD,
Rita K Kabaso,
Robert J Ham,
Robin P Mathew,
Ross J Grigsby,
Russell K Riley,
Samina S Khan,
Sandra A Hughes,
Sangeeta M Khurana, PhD,
Sean R Marcsisin,
Sherry G Bous,
Shirley J Berryman,
Sixto M Mercado Rios,
Sneha S Patel,
Sony Mathews,
Sonya M Edmonds,
Stephen J Mottola,
Steven D Kehoe,
Susan D Yuscius,
Susan P Bruederle,
Tamika White,
Tamil Arasu, PhD,
Thomas J Arista,
Toyin B Oladimeji,
Wayne E Seifert,
William A Warnick,
William Hallett, PhD,
William L Bargo,
Xu Michael Di, PhD,
Yun Wu, PhD,
Yvonne E Lozano,
Zhong Li, PhD
Kshitij A Patkar's Documents
Publish Date | Document Type | Title |
---|---|---|
March, 2017 | FDA 483 | Sigma-Aldrich Manufacturing LLC - Form 483, 2017-03-10 |
June, 2019 | FDA 483 | Ajanta Pharma Limited - Form 483, 2019-06-22 |
March, 2017 | EIR | Sigma-Aldrich Manufacturing LLC - EIR, 2017-03-10 |
May, 2013 | FDA 483 Response | Rising Pharma Holdings, Inc. - Form 483R, 2013-05-03 |
March, 2013 | FDA 483 | Ambiopharm, Inc. - Form 483, 2013-03-28 |
August, 2017 | FDA 483 | Mylan Pharmaceuticals Inc. - Form 483, 2017-08-25 |
May, 2013 | FDA 483 | Rising Pharma Holdings, Inc. - Form 483, 2013-05-03 |
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](/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