FDA Investigator Tekalign Wondimu
Tekalign Wondimu has conducted inspections on 25 sites in 3 countries as of 17 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.
Investigator Details
Number of Inspected Sites:
25
Last Inspection Date:
17 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
China,
United States of America,
Canada
FDA Investigators that have inspected at least one site in common with Tekalign Wondimu:
Albert A Salvador,
Amy N Chen,
Anastasia G Lolas,
Anastasia M Shields,
Anita R Michael,
Anthony A Charity,
Ariel Cruz Figueroa,
Audrey Thereset Uy,
Azeezat M Lawal,
Bill Tacket, Jr,
Christina K Theodorou,
Christopher T Middendorf,
Craig D Zagata,
Daniel J Min,
Daniel W Johnson,
David A Oluwo,
David J Eide,
David J Hafner,
Deborah J Parris,
Debra J Bennett,
Debra L Pagano,
Demitria J Xiradakis,
Denise M Digiulio,
Diane T Bargo,
Dongping Dai, PhD,
Douglas C Kovacs,
Dr. Gerald E Poly,
Edward P Potter,
Elaine E Gilfillan,
Ephrem Hunde, PhD,
Eric Rothschild,
Evan Tong,
George Pyramides,
Hala L Selby,
Helen Verdel,
James A Liubicich,
James M Mason,
James P Mcevoy,
Jawaid Hamid,
Jay T Wong,
Joel D Hustedt,
Johnna L Bleem,
Johnny D Nwankwo,
Jose M Cayuela,
Joseph L Despins, PhD,
Joseph W Matthews,
Juan Rjimenez Garcia,
Juanita P Versace,
Julianne C Mccullough,
Justin A Boyd,
Kara D Dobbin,
Kara J Wright,
Karen A Briggs,
Karyn M Campbell,
Keith M Reilly,
Kendra L Brooks,
Kristen D Evans,
Kristina J Donohue,
Lawrence Harmon, Jr,
LCDR Susan E Polifko,
Lisa B Orr,
LT John M Mastalski,
Marcellinus D Dordunoo,
Marcus A Ray,
Marie A Fadden,
Martha Sullivan Myrick,
Matthew R Noonan,
Melkamu Getie Kebtie, PhD,
Meredith L Sheridan,
Michael A Taylor,
Michael D Omeara,
Michael L Casner,
Michael R Klapal,
Mindy M Chou,
Nancy F Scheraga,
Nebil A Oumer,
Nikisha M Bolden,
Pamela N Agaba,
Paul L Bellamy,
Peter E Baker,
Philip F Istafanos, DMV, MS,
Philip Kreiter,
Prabhu P Raju,
Qin Xu,
Rachael A Moliver,
Rachael O Oyewole,
Rachel C Harrington,
Reba A Gates,
Roger F Zabinski,
Rose Xu,
Roseline N Boateng,
Ruben C Quintana,
Satheesh Thomas,
Sena G Dissmeyer,
Simone E Pitts,
Sony Mathews,
Stacey A Priest,
Stephanie L Shapley,
Stephanie Mangigian, MS/OSH, RN,
Steven D Kehoe,
Steven P Donald,
Susan F Laska, MS,
Tammy L Chavis,
Tania E Vizcaino,
Tanya R Syffrard,
Thomas E Friel,
Timothy T Kapsala,
Tricia S Martinez,
Vlada Matusovsky,
William J Leonard,
Yaharn Su,
Yessika Mashinski,
Yiyue Zhang (nmi), PhD,
Yvonne C Mcknight,
Zhao Wang, PhD,
Zhong Li, PhD
Tekalign Wondimu's Documents
| Publish Date | Document Type | Title |
|---|---|---|
| June, 2022 | FDA 483 | Dercher Enterprises, Inc., DBA Gordon Laboratories - Form 483, 2022-06-13 |
| July, 2023 | FDA 483 | Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) - Form 483, 2023-07-14 |
| June, 2021 | FDA 483 | Granules Pharmaceuticals Inc. - Form 483, 2021-06-25 |
| October, 2021 | EIR | Frontage Laboratories, Inc. - EIR, 2021-10-15 |
| August, 2022 | FDA 483 | ImprimisRx NJ - Form 483, 2022-08-05 |
| December, 2023 | FDA 483 | Granules Pharmaceuticals Inc. - Form 483, 2023-12-15 |
| September, 2023 | FDA 483 | Pine Pharmaceuticals, LLC - Form 483, 2023-09-19 |
| March, 2022 | FDA 483 | Elementis SRL, Inc. - Form 483, 2022-03-17 |
| October, 2021 | FDA 483 | Frontage Laboratories, Inc. - Form 483, 2021-10-15 |
| May, 2023 | FDA 483 | West Services and Solutions LLC - Form 483, 2023-05-18 |
| October, 2021 | FDA 483 Response | Frontage Laboratories, Inc. - Form 483R, 2021-11-04 |
| August, 2024 | FDA 483 | Biolog, Inc. - Form 483, 2024-08-15 |
| September, 2024 | FDA 483 | Annovex Pharma, Inc. - Form 483, 2024-09-06 |
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