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:
100003783
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
February, 2025 FDA 483 Veltek Associates, Inc. - Form 483, 2025-02-06
March, 2024 FDA 483 Sunshine Lake Pharma Co., Ltd. - Form 483, 2024-03-22
November, 2024 FDA 483 Finecure Pharmaceuticals LTD. - Form 483, 2024-11-22
April, 2023 FDA 483 MARS FISHCARE NORTH AMERICA, INC. - Form 483, 2023-04-07
May, 2025 FDA 483 STAQ Pharma of Ohio, LLC - Form 483, 2025-05-16
August, 2025 FDA 483 Sumitomo Pharma Co., Ltd. - Form 483, 2025-08-07
August, 2025 FDA 483 Juzen Chemical Corporation - Form 483, 2025-08-01
July, 2025 FDA 483 Lead Chemical Co., Ltd. - Form 483, 2025-07-24

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