FDA Person
FDAErik W. Koester
View detailed information about Erik W. Koester, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 91 inspections of 81 companies, 2016–2026.
Inspections (91)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| August 21, 2026 | Auro Peptides Limited | Not classified | #1331922 | |
| August 14, 2026 | MSN Laboratories Private Limited | Not classified | #1330056 | |
| June 15, 2026 | Fayetteville VA Medical Center | Not classified | Drug Quality Assurance | #1322070 |
| May 22, 2026 | Cambridge Isotope Laboratories, Inc. | Not classified | #1318354 | |
| April 8, 2026 | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC | Not classified | #1311392 | |
| March 5, 2026 | Berkshire Sterile Manufacturing, LLC | Not classified | Drug Quality Assurance | #1305732 |
| January 22, 2026 | Anika Therapeutics, Inc. | Not classified | Monitoring of Marketed Animal Drugs, Feeds, and Devices | #1281778 |
| December 12, 2025 | Azurity Pharmaceuticals, Inc. | NAI | Drug Quality Assurance | #1297348 |
| November 4, 2025 | PETNET Solutions Inc. | VAI | Drug Quality Assurance | #1290272 |
| September 30, 2025 | The General Hospital Corporation | VAI | Generic Drug Evaluation | #1284676 |
| September 9, 2025 | Charles River Laboratories, Inc. | VAI | Drug Quality Assurance | #1281548 |
| August 8, 2025 | Hikma Injectables USA Inc | Not classified | Drug Quality Assurance | #1278072 |
| July 1, 2025 | Cardinal Health 414 LLC | VAI | Drug Quality Assurance | #1274365 |
| June 5, 2025 | GF Health Products, Inc. | Not classified | Drug Quality Assurance | #1272752 |
| May 20, 2025 | Ipsen Bioscience, Inc. | Not classified | #1270829 | |
| May 20, 2025 | Ipsen Pharma Biotech | NAI | Drug Quality Assurance | #1270829 |
| April 30, 2025 | Johnson & Johnson Private Limited | Not classified | #1269479 | |
| April 25, 2025 | Viyash Life Sciences Private Limited | Not classified | #1268018 | |
| April 18, 2025 | Sharon Bio-Medicine Ltd | Not classified | #1267146 | |
| March 20, 2025 | G. C. Hanford Manufacturing Co | OAI | Drug Quality Assurance | #1264589 |
Documents (76)
- EIR · Strem Chemicals, Inc. · January 27, 2020
- 483 · Edge Pharma, LLC · March 30, 2020
- 483 · Johnson Memorial Cancer Center · October 19, 2018
- 483 · South Berwick Pharmacy Seacoast Compounding, Inc. · September 30, 2022
- 483 · Edge Pharma, LLC · November 30, 2021
- 483 · New England Life Care, Inc. dba Advanced Compounding Solutions · August 22, 2017
- 483 · Hikma Injectables USA Inc · August 8, 2025
- EIR · Rhodes Pharmaceuticals, L.P. · July 27, 2016
- 483 · Brookfield Medical/Surgical Supplies, Inc. · December 21, 2018
- EIR · Associates of Cape Cod, Inc. · November 26, 2019
- EIR · Pharmaceutics International, Inc. · November 14, 2022
- 483 · Charles River Laboratories, Inc. DBA Charles River, Endosafe · September 9, 2025
- 483 · Cardinal Health 414 LLC · July 1, 2025
- EIR · Pharmaceutics International Inc · November 14, 2022
- 483 · Anika Therapeutics, Inc. · January 22, 2026
- 483 · Berkshire Sterile Manufacturing, LLC · March 5, 2026
- EIR · Pharmaron Manufacturing Services (US) LLC · July 27, 2016
- 483 · PolyPeptide Laboratories Private Limited · November 22, 2024
- 483 · Anika Therapeutics, Inc. · August 9, 2023
- 483 · Berkshire Sterile Manufacturing, LLC · May 23, 2022
- 483 · Anika Therapeutics, Inc. · September 21, 2017
- EIR · Azurity Pharmaceuticals, Inc. · February 24, 2022
- 483 · Biogen, Inc. · April 6, 2017
- 483 · Azurity Pharmaceuticals, Inc. · February 24, 2022
- 483 · Azurity Pharmaceuticals, Inc. · February 19, 2025
- 483 · GF Health Products, Inc. · June 5, 2025
- 483 · G. C. Hanford Manufacturing Co · March 20, 2025
- 483 · The General Hospital Corporation · September 30, 2025
- 483 · Viyash Life Sciences Private Limited · April 25, 2025
- 483 · Shawsheen Rubber Co., Inc. dba Arrowhead Athletics · March 13, 2023
- 483 · scPharmaceuticals Inc. · January 25, 2024
- 483 · Charles River Laboratories, Inc. · February 11, 2020
- 483 · Rhodes Technologies · July 27, 2016
- 483 · Safecor Health, LLC · June 24, 2024
- EIR · Berkshire Sterile Manufacturing, LLC · April 13, 2018
- 483 · Safecor Health, LLC · October 19, 2017
- 483 · Fresenius Kabi Compounding, LLC · December 4, 2018
- 483 · Ensign Laboratories Proprietary Ltd · July 15, 2022
- 483 · TAYCA CORPORATION · December 1, 2023
- 483 · Chartwell Pharmaceuticals Amityville, LLC · December 21, 2022
- 483 · Lohxa, LLC · July 19, 2021
- 483 · Safecor Health, LLC · October 27, 2015
- 483 · Ariad Pharmaceuticals · May 31, 2017
- 483 · South Berwick Pharmacy Seacoast Compounding, Inc. · September 30, 2022
- 483 · EyePoint Pharmaceuticals, Inc. · August 28, 2019
- 483 · Cardinal Health 414 LLC · July 1, 2025
- 483 · Broder Bros., Co · September 20, 2019
- 483 · Sun Pharmaceutical Industries, Inc. · December 23, 2019
- 483 · Nitto Denko Avecia Inc. · February 8, 2023
- 483 · PETNET Solutions Inc. · November 4, 2025
- 483 · Charles River Laboratories, Inc. · September 9, 2025
- 483 · Brigham and Women's Hospital · September 16, 2021
- 483 · Edge Pharma, LLC · March 30, 2020
- 483 · Edge Pharma, LLC · November 30, 2021
- 483 · Hopkinton Drug, Inc. · November 2, 2020
- 483 · ALK-Abello, Inc. · March 1, 2019
- 483 · Pharmaceutics International Inc · November 14, 2022
- 483 · Baxter Laboratories Pty. Ltd.
- 483 · PLZ Corp · January 15, 2025
- 483 · Molecular Ms Diagnostics, LLC · April 16, 2024
- EIR · Trividia Manufacturing Solutions, Inc. · August 24, 2018
- 483 · The Tender Corporation · April 26, 2023
- 483 · Pharmaceutics International, Inc. · November 14, 2022
- EIR · LBB Specialties Holdings LLC · June 26, 2019
- EIR · Nitto Denko Avecia Inc. · May 10, 2018
- 483 · Lyophilization Services of New England, Inc. (LSNE) D/B/A PCI Pharma Services · September 27, 2023
- 483 · Associates of Cape Cod, Inc. · November 26, 2019
- 483 · LBB Specialties Holdings LLC · June 26, 2019
- 483 · Brookfield Medical/Surgical Supplies, Inc. · April 4, 2022
- EIR · Charles River Laboratories, Inc. · September 9, 2025
- 483 · Azurity Pharmaceuticals, Inc. · January 15, 2020
- 483 · Homeocare Laboratories, Inc. · March 20, 2024
- 483 · Titan Kogyo, Ltd. · December 8, 2023
- 483 · Fayetteville VA Medical Center · June 15, 2026
- 483 · Auro Peptides Limited · August 21, 2026
- 483 · MSN Laboratories Private Limited · August 14, 2026
Frequently inspected with (10)
Robert J. Martin
12 shared
John P. Mistler
Arizona Market President
10 shared
Sean R. Marcsisin
Senior Consumer Safety Officer - Pharmaceutical Quality
8 shared
Armen H. Youssoufian
4 shared
Jonathan G. Matrisciano
Program Division Director/District Director
3 shared
JoshRenzo N. Ramilo
3 shared
Syeda N. Mahazabin
Drug Investigator
3 shared
Eric M. Silberhorn
2 shared
Harlan J. Howard
2 shared
Holly M. Zahner
2 shared
Person Information
Name
Erik W. Koester
Title
Investigator
Role
Regulatory Personnel
ID: 2bbab081-6783-40a1-83c1-b219bde22bd1
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