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Michael Serrano

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FDA investigator. Took part in 130 inspections of 114 companies, 2016–2026.

Inspections (130)
DateCompanyClassificationProject areaInspection
September 25, 2026Janssen Pharmaceuticals, IncVAIPostmarket Surv. and Epidemiology#1338168
September 3, 2026Impulse Dynamics (USA), Inc.Not classified#1336660
August 19, 2026GSK LLC (GlaxoSmithKline)Not classified#1318026
July 24, 2026SUN PHARMACEUTICAL INDUSTRIES INCNot classifiedBioresearch Monitoring#1328400
June 11, 2026Qing WenNot classified#1324516
June 4, 2026Guomin XiaoNot classified#1323466
May 20, 2026Elevar Therapeutics, Inc.Not classifiedBioresearch Monitoring#1318414
April 28, 2026Bristol Myers SquibbNot classified#1316958
March 30, 2026Clinilabs, LLCNot classified#1312114
March 10, 2026Acadia Pharmaceuticals Inc.Not classified#1309598
January 28, 2026Kevin MaNot classified#1302586
December 12, 2025Bristol-Myers Squibb CompanyNot classified#1299176
November 6, 2025BeOne Medicines USA, Inc.NAIBioresearch Monitoring#1293402
October 28, 2025Vinay Sikand, M.D.Not classified#1290456
September 19, 2025Verity Pharmaceuticals Inc.Not classified#1283942
September 19, 2025Verity Pharmaceuticals Inc.NAIBioresearch Monitoring#1283942
September 10, 2025Fox Chase Cancer Center IRBNAIBioresearch Monitoring#1283950
August 26, 2025Prinston Pharmaceutical IncNot classified#1260044
July 25, 2025Jinhai ZhuNAIBioresearch Monitoring#1279024
July 18, 2025Yu Ren, M.D., Ph.D.NAIBioresearch Monitoring#1279041
See all 130 inspections in the dashboard
Documents (61)
  • EIR · Rho, Inc. · June 30, 2017
  • EIR · Ranbaxy Inc. · June 20, 2017
  • 483 · Englewood Hospital and Medical Center IRB · November 26, 2019
  • EIR · John L. Berk, M.D. · June 21, 2018
  • 483 · Wissam Abouzgheib, MD · January 29, 2018
  • 483 · SK Life Science Inc. · August 11, 2021
  • 483 · Nationwide Laboratories, LLC · November 27, 2018
  • EIR · Amerigen Pharmaceuticals Inc. · January 18, 2019
  • 483 · St. Peter's University Hospital - CPHSR · February 8, 2019
  • EIR · Allergan · April 11, 2019
  • 483 · Dipakkumar P. Pandya, M.D. · February 1, 2024
  • 483 · Tris Pharma Inc. · March 8, 2024
  • EIR · Actavis Elizabeth LLC, A Company of Teva · April 26, 2011
  • 483 · Merck & Co. Inc · November 19, 2015
  • 483 · Bausch Health US., LLC. · November 7, 2024
  • 483 · Insmed Incorporated · April 3, 2025
  • EIR · Bristol Myers Squibb · February 2, 2022
  • 483 · Ida Vanessa Doederlein Schwartz, MD · January 31, 2025
  • 483 · Alvogen, Inc · June 10, 2021
  • 483 · Robert Wood Johnson U Hosp @ Hamilton IRB · December 22, 2021
  • 483 · Ahsan A. Abdulghani, M.D. · August 21, 2023
  • EIR · SK Life Science Inc. · August 11, 2021
  • 483 · Carlos Lastra MD · January 13, 2020
  • 483 · Allergan, PLC. · April 11, 2019
  • 483 · Merck & Co. Inc · August 26, 2016
  • 483 · Teva Pharmaceuticals USA, Inc · September 29, 2023
  • EIR · Leading Pharma, LLC · August 11, 2020
  • 483 · Alvogen, Inc · September 11, 2020
  • 483 · Eugenia Girda, MD · October 18, 2022
  • 483 · St. Peter's University Hospital - CPHSR · July 4, 2019
  • EIR · Mitsubishi Tanabe Pharma Development America, Inc. · October 15, 2021
  • EIR · John L. Berk, M.D. · July 22, 2021
  • 483 · Deborah A. Goss, M.D. · March 17, 2025
  • EIR · Clario (BioClinica, Inc.) · September 26, 2019
  • 483 · Vinay Sikand, M.D. · September 14, 2023
  • EIR · Covance Laboratories Inc. · July 26, 2017
  • 483 · Navinta, LLC · March 28, 2019
  • 483 · Colgate-Palmolive Company · May 30, 2019
  • 483 · Fresenius Medical Care Holdings, Inc. · August 2, 2019
  • 483 · Stephen S. Kasparian, MD · September 2, 2021
  • 483 · Steven David, M.D. · January 8, 2018
  • EIR · APCER Life Sciences, Inc. · June 21, 2016
  • EIR · Janssen Pharmaceuticals Inc. · January 22, 2016
  • 483 · Larken Laboratories, Inc. · October 8, 2020
  • 483 · Sanofi US · August 3, 2016
  • 483 · RISING PHARMACEUTICALS INC · January 28, 2019
  • 483 · Quagen Pharmaceuticals LLC · November 8, 2023
  • EIR · Bristol-Myers Squibb Company · June 27, 2018
  • 483 · Actavis Elizabeth LLC, A Company of Teva · April 26, 2011
  • 483 · Bausch Health US., LLC. · June 16, 2021
  • 483 · Robert S. Falcone, M.D. · April 5, 2021
  • EIR · Clario Inc · January 10, 2022
  • 483 · Ascend Laboratories, LLC · November 10, 2021
  • 483 · Nikolaos T. Pyrsopoulos, M.D. · February 22, 2022
  • 483 · Rho, Inc. · June 30, 2017
  • EIR · Catalent Pharma Solutions, LLC · July 13, 2018
  • 483 · Dr. Reddy's Laboratories, Inc. · May 26, 2022
  • EIR · Wissam Abouzgheib, MD · January 29, 2018
  • 483 · Mitsubishi Tanabe Pharma Development America, Inc. · October 15, 2021
  • 483 · Elevar Therapeutics, Inc. · May 20, 2026
  • 483 · SUN PHARMACEUTICAL INDUSTRIES INC · July 24, 2026
Frequently inspected with (10)
Mayar M. Mussa
9 shared
Jay B. Shah

Investigator

8 shared
Shirley S. Wen
7 shared
Nina Yang

investigator

4 shared
Tyanna N. Hadley

investigator

3 shared
Anastasia I. Onuorah

investigator

2 shared
Ashley J. Burns
2 shared
Byungja E. Marciante
2 shared
Jean M. Mulinde
2 shared
Peter R. Lenahan

Regulatory Officer

2 shared
Person Information

Name

Michael Serrano

Title

investigator

Role

COMPANY REP

ID: 44c9d307-9d78-4480-b1d0-36096c056642

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