FDA Person
FDAKellie B. Kelm
View detailed information about Kellie B. Kelm, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 6 inspections of 6 companies, 2024.
Inspections (6)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| December 19, 2024 | Chartwell Pharmaceuticals LLC | Not classified | Drug Quality Assurance | #1257321 |
| November 12, 2024 | Taylor Farms Colorado, Inc. | VAI | Foodborne Biological Hazards | #1253867 |
| November 12, 2024 | Portable Therapeutix | NAI | Postmarket Assurance: Medical Devices | #1253785 |
| September 30, 2024 | University of Utah Cell Therapy and Regenerative Medicine | VAI | Human Cellular, Tissue, and Gene Therapies | #1229003 |
| September 27, 2024 | Janssen Pharmaceuticals, Inc | NAI | Bioresearch Monitoring: Human Drugs | #1229931 |
| September 13, 2024 | Pedro A. Velasquez-Mieyer, M.D. | VAI | Bioresearch Monitoring: Human Drugs | #1249188 |
Documents (28)
- WARNING LETTER · Cardinal Health · December 20, 2023
- WARNING LETTER · Dr. Joel Kaplan Inc. · June 30, 2023
- WARNING LETTER · WISSNER-BOSSERHOFF GMBH · April 25, 2024
- WARNING LETTER · Jiangsu Shenli Medical Production Co., Ltd. · March 19, 2024
- WARNING LETTER · Medline Industries, LP · January 22, 2024
- WARNING LETTER · Sol-Millennium Medical, Inc. · December 20, 2023
- WARNING LETTER · Fresenius Kabi AG · September 7, 2023
- 483 · BSO LLC · July 16, 2025
- WARNING LETTER · Jiangsu Shenli Medical Production Co., Ltd. · March 29, 2024
- WARNING LETTER · Jiangsu Caina Medical Co., Ltd · March 23, 2024
- 483 · Alembic Pharmaceuticals Limited · August 30, 2022
- 483 · Ecometics, Inc.
- 483 · MPP GROUP, LLC · June 7, 2024
- 483 · XGen Pharmaceuticals DJB, Inc. · July 14, 2024
- 483 · Choice All Natural, Inc. dba Om Botanical · December 2, 2022
- 483 · R.R. Importaciones Inc. · October 5, 2023
- EIR · Frontage Laboratories, Inc. · March 8, 2018
- EIR · PPD Development, L.P. · May 18, 2018
- EIR · Keith DeDonder, DVM, Dip. ACPV · October 4, 2016
- 483 · Lupin Limited · September 8, 2023
- 483 · Portable Therapeutix · November 12, 2024
- 483 · Chartwell Pharmaceuticals LLC · December 19, 2024
- 483 · University of Utah Cell Therapy and Regenerative Medicine · September 30, 2024
- 483 · G.N.R. Group Co., LTD. · January 23, 2024
- 483 · Pedro A. Velasquez-Mieyer, M.D. · September 13, 2024
- 483 · Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC · July 23, 2021
- 483 · Janssen Pharmaceuticals, Inc · September 27, 2024
- 483 · Taylor Farms Colorado, Inc. · November 12, 2024
Person Information
Name
Kellie B. Kelm
ID: df5eaff8-c13d-49e8-b2f6-c3d42a9a7daf
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