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FDA Person
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Jacob G. Lutz

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FDA investigator. Took part in 35 inspections of 33 companies, 2023–2025.

Inspections (35)
DateCompanyClassificationProject areaInspection
December 10, 2025Medtronic, Inc.VAIDrug Quality Assurance#1294794
November 4, 2025Grand River Aseptic Manufacturing Inc.VAIDrug Quality Assurance#1293366
November 4, 2025Grand River Aseptic Manufacturing, Inc.VAIDrug Quality Assurance#1293364
October 20, 2025ENDO USA, Inc.OAIDrug Quality Assurance#1287690
September 11, 2025Eli Lilly and CompanyVAINew Drug Evaluation#1282100
August 12, 2025Fareva Morton GroveNot classifiedDrug Quality Assurance#1278907
June 20, 2025MSD International GmbH (Singapore Branch)Not classified#1274306
June 13, 2025Aventis Pharma Manufacturing Pte. Ltd.Not classified#1274305
June 6, 2025Astellas Pharma Inc.Not classified#1274304
May 20, 2025Eli Lilly & CompanyVAIDrug Quality Assurance#1270621
April 30, 2025PETNET Solutions, IncNot classified#1270872
April 17, 2025Cayman Chemical Company, Inc.Not classified#1267154
March 19, 2025L. Perrigo CompanyVAIDrug Quality Assurance#1251186
February 18, 2025King Pharmaceuticals LLCOAIDrug Quality Assurance#1261579
January 17, 2025Hospira, Inc., A Pfizer CompanyVAIDrug Quality Assurance#1255699
November 20, 2024Patheon Biologics LLCNot classified#1251864
November 12, 2024Taylor Farms Colorado, Inc.VAIFoodborne Biological Hazards#1253867
October 29, 2024Mol Belting SystemsOAIDrug Quality Assurance#1252945
October 17, 2024CFB Michigan IncVAIDrug Quality Assurance#1252169
September 6, 2024Solventum US LLCVAIDrug Quality Assurance#1248520
See all 35 inspections in the dashboard
Documents (48)
  • 483 · SmF Holdings, LLC · March 2, 2023
  • EIR · Gilead Sciences, Inc. · December 17, 2021
  • 483 · Spartan Chemical Co Inc · December 12, 2022
  • EIR · Cosmax USA, Inc. · July 22, 2022
  • 483 · Medtronic, Inc. · December 10, 2025
  • 483 · Biological Research Solutions, Inc. · November 29, 2021
  • 483 · Haleon US Inc. · September 30, 2021
  • 483 · Eli Lilly & Company · May 20, 2025
  • 483 · Grand River Aseptic Manufacturing, Inc. · November 4, 2025
  • 483 · Grand River Aseptic Manufacturing Inc. · November 4, 2025
  • 483 · CFB Michigan Inc · October 17, 2024
  • 483 · Astellas Pharma Inc. · June 6, 2025
  • 483 · Patheon Biologics LLC · November 20, 2024
  • 483 · L. Perrigo Company · March 19, 2025
  • 483 · Cayman Chemical Company, Inc. · April 17, 2025
  • 483 · Eli Lilly and Company · September 11, 2025
  • 483 · MSD International GmbH (Singapore Branch) · June 20, 2025
  • 483 · Spartan Chemical Co Inc · March 26, 2021
  • 483 · Grato Holdings, Inc. · December 6, 2019
  • 483 · Solventum US LLC · September 6, 2024
  • 483 · ENDO USA, Inc. · October 20, 2025
  • 483 · Washington University School of Medicine · March 21, 2024
  • 483 · Grand River Aseptic Manufacturing Inc. · September 29, 2023
  • 483 · Vortech Pharmaceuticals Ltd · February 9, 2022
  • 483 · Metrex Research, LLC. · May 20, 2022
  • 483 · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · March 6, 2020
  • 483 · SNF Holdings, LLC dba Vios Compounding · March 2, 2023
  • 483 · King Pharmaceuticals LLC · October 21, 2019
  • 483 · Marcus Research Laboratory, Inc. · September 2, 2022
  • 483 · ENDO USA, Inc. · April 14, 2023
  • 483 · Missouri Analytical Laboratories, Inc. · September 2, 2022
  • 483 · Avlon Industries, Inc · January 24, 2023
  • EIR · Ferndale Laboratories, Inc. · March 4, 2022
  • 483 · Zoetis Manufacturing & Research Spain, S.L. · July 28, 2023
  • 483 · Pharmacia & Upjohn Company LLC · June 16, 2023
  • 483 · Fareva Morton Grove · August 12, 2025
  • 483 · King Pharmaceuticals LLC · February 18, 2025
  • 483 · Gilead Sciences, Inc. · December 17, 2021
  • 483 · Hospira, Inc., A Pfizer Company · January 17, 2025
  • 483 · HNC Products Inc. · August 24, 2021
  • 483 · Cosmax USA, Inc. · July 22, 2022
  • 483 · Isotopia Molecular Imaging Ltd (Soreq Site) · November 8, 2022
  • 483 · Akron Coating & Adhesives Inc · June 27, 2022
  • 483 · Mol Belting Systems · October 29, 2024
  • 483 · Ferndale Laboratories, Inc. · March 4, 2022
  • 483 · Akorn, Inc. · April 8, 2022
  • 483 · Catalent Indiana, LLC · November 15, 2023
  • 483 · Taylor Farms Colorado, Inc. · November 12, 2024
Frequently inspected with (10)
Joohi Castelvetere
6 shared
Anna M. Spiros
3 shared
Nicholas J. Presto
3 shared
Elizabeth R. Bloom
2 shared
Geoffrey K. Kilili

investigator

2 shared
Joseph A. Piechocki
2 shared
Melissa M. Steiger
2 shared
Rafeeq A. Habeeb

Investigator

2 shared
Ramia Brzenjy
2 shared
Shannon L. Maisano
2 shared
Person Information

Name

Jacob G. Lutz

Title

Investigator

Role

Regulatory Personnel

ID: ca2710c6-064f-4728-9129-aad73e74f12d

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