FDA Investigator CDR Donald Ertel
CDR Donald Ertel has conducted inspections on 16 sites in 6 countries as of 21 Aug 2023. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
16
Last Inspection Date:
21 Aug 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
France,
United States of America,
Mexico,
Germany,
Ireland,
Denmark
FDA Investigators that have inspected at least one site in common with CDR Donald Ertel:
Alan L Truong,
Alexey Khrenov, PhD,
Alicia M Mozzachio,
Amy Hsu, PhD,
Andrew "Drew" Haack, PhD,
Andrew K Haack, PhD,
Anita Narula, PhD,
Anita R Michael,
Ann Marie Montemurro,
Ann Marie Schofield,
Arie C Menachem,
Azza Talaat,
Barbara Janine Breithaupt,
Barbara M Frazier,
Bijoy Panicker,
Bradley Dworak, PhD,
Brentley S Collins,
Brian M Janelsins, PhD,
Bruce D Meade,
Burnell M Henry,
CDR Cecily Jones,
Charles Yuanchia Kuo, PhD,
Chava Kimchi Sarfaty, PhD,
Christian D Lynch (CDL),
Christine A Harman, PhD,
Christopher R Czajka,
Colleen F Hoyt,
Craig D Zagata,
Cynthia Jim, CSO,
Cynthia L Kelley,
Daniel C Kearns,
David E Bailey,
Deborah M Trout,
Destry M Sillivan,
Devaughn Edwards,
Dino A Fiegelstock,
Donna D Gallien, MPH,
Dr. Gang Wang, PhD,
Dr. Willie F Vann, PhD,
Edmund F Mrak, Jr,
Eliezar Ramos,
Gene D Arcy,
Graeme E Price,
Graeme Price,
Hailin Wang (Sheena), PhD,
Helen B Ricalde,
Hoda N Abadeer,
Holly Brevig,
J David Doleski,
Jacqueline Mdiaz Albertini,
Jakob Reiser, PhD,
James E Keller, PhD,
James M Mason,
James R Evans,
Jean Lhu Primmer,
Jennifer L Bridgewater,
Jennifer L Schmidt,
Jeremy W Rotton,
Jessica Chery,
Joan A Loreng,
Joan Johnson,
John F Cipollo,
John M Mcinnis,
José E Meléndez,
Joseph George,
Joshua J Silvestri,
Julie D Bringger,
Justin A Boyd,
Kathryn E King,
Kelly R Lewis,
Kevin P Foley,
Kristy A Zielny,
Kula N Jha,
Laressa R Gray,
Laura Fontan, MS,
Laurel A Beer,
Lauren M Lilly, PhD,
Laurie P Norwood,
LCDR Debra Emerson,
Linda Thai,
Lisa K Capron,
Lisa P Oakes,
Lori Peters,
Lydia S Chan,
Madushini Dharmasena, PhD,
Marion Michaelis,
Mariza M Jafary,
Marsha W Major,
Meisha R Sampson,
Meisha Waters,
Melanie L Drayton,
Michael C Kennedy, PhD,
Michael Havert, PhD,
Michael S Araneta,
Michael Shanks, MS,
Michele L Forster, PhD,
Michele L Obert,
Mihaly S Ligmond,
Mikhail V Ovanesov, PhD,
Mra Davism,
Myra K Casey,
Nancy T Waites,
Nataniel Phillips Sylvain, PhD,
Nicole K Trudel,
Nikisha M Bolden,
Omotunde O Osunsanmi,
Patrick C Klotzbuecher,
Patsy J Domingo,
Paula A Trost,
Phillip C Thai,
Prabhu P Raju,
Prajakta A Varadkar,
Rabia Ballica, PhD,
Ralph A Erickson,
Ramon E Martinez,
Rebecca K Olin,
Reyes Candau Chacon, PhD,
Richard Heath Coats,
Richard Ledwidge (nmi), PhD,
Richard W Thornton,
Riley C Myers, PhD,
Robert C Coleman,
Robert Jennings,
Robert Sausville,
Robert W Fisher,
Rose Ashley,
S Lori Brown, PhD MPH,
Sarah B Tanksley,
Scott E Norris,
Scott T Ballard,
Sharon K Thoma, PharmD,
Sidney B Priesmeyer,
Simone E Pitts,
Solomon Yimam (SY),
Steven B Hertz,
Steven C Derrick,
Steven E Bowen, PhD,
Steven Fong, MS, PhD,
Susan F Laska, MS,
Susan M Jackson,
Teegan Dellibovi Ragheb, PhD,
Thuy T Nguyen, LCDR,
Tina S Roecklein,
Unnee Ranjan,
V Teres Speer,
Vanessa Y Gelsey, PhD,
Vanessa Y Jacobs,
Wayne E Seifert,
Wei Wang, PhD,
William D Tingley,
Xu Michael Di, PhD,
Yideng Liang,
Yonggang Wang, PhD,
Yuan Chia Kuo,
Yumi J Hiramine,
Zhaohui Ye,
Zhenzhen Liu, PhD,
Zhong Li, PhD,
Zhongren Wu
CDR Donald Ertel's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| June, 2017 | FDA 483 | SAFC Carlsbad Inc. - Form 483, 2017-06-22 |
| October, 2015 | EIR | AGC Biologics A/S - EIR, 2015-10-13 |
| June, 2017 | FDA 483 | KITE PHARMA, INC. - Form 483, 2017-06-16 |
| August, 2018 | FDA 483 | Laboratorios Silanes, S.A. de C.V. - Form 483, 2018-08-03 |
| June, 2017 | EIR | KITE PHARMA, INC. - EIR, 2017-10-18 |
| April, 2016 | FDA 483 | AGC Biologics, Inc. - Form 483, 2016-04-22 |
| June, 2011 | FDA 483 | Instituto Bioclon S.A. de C.V. - Form 483, 2011-06-22 |
| June, 2017 | FDA 483 Response | KITE PHARMA, INC. - Form 483R, 2017-06-29 |
| March, 2022 | EIR | Kite Pharma, Inc. - EIR, 2022-04-05 |
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.
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