FDA Investigator Michael Serrano

Michael Serrano has inspections in 12 countries as of 01 Feb 2024. Michael Serrano has collaborated with a combinined 6079 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
245
Last Inspection Date:
01 Feb 2024
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Taiwan, Canada, Japan, Cayman Islands, Malaysia, Philippines, Thailand, France, India, Ethiopia, New Zealand
Co-Investigator(s):
A Williams, Addam S Reynolds, Adetutu M Gidado, Alan R Condon, Alberto A Viciedo, Alice S Tsao, Alicia A Dalley, Allen Lou, Amanda E Lewin, PhD, Amatul H Marium, Amy A Johnson, Amy Franklin, Amy L Singer, Amy Lynn Frankshun, PhD, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia I Offordile, Ankur C Patel, Ann Marie Montemurro, Anna Kevilag, Anna Kwilas, Annemarie Bodnar, Annet R Rajan, Anthony J Donato, Arie C Menachem, Arindam Dasgupta, PhD, Ashley J Burns, Atul J Agrawal, Barbara D Wright, Barbara J Maulfair, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Bei Yu, Betsy C Galliher, Byungja E Marciante, Byungja E Mercuente, Byungja H Marciante, Byunja E Marciante, Cara M Minelli, Cary Greene, Charisse K Green, Charles A Snipes, PhD, Charles J Chacko, Charles M Edwards, Cheryl A Grandinetti, Christina N Maurino, Christina P Burkhart, Christine M Cerenzio, Cody D Rickman, Constantin Y Philopoulos, Courtney N Long, Craig A Garmendia, Craig W Swanson, Cynthia E Bushee, Cynthia F Kleppinger, MD, D Jenny Argiropoulos, Dan Grabicki, Daniel J Grabicki, Daniel L Zheng, Darin S Wiegers, Daryl A Dewoskin, Dave M Deroche, David E Bailey, David H Smith, David P Vanhouten, Dawa L Wydner, Dawn C Olenjack, Dawn L Wydner, Dawn L Wyndver, Deborah B Nixon, Debra A Taylor, Debra L Boyd Seale, Demitria J Xiradakis, Denise M Visco, Investigator, Denise M Visu, Dien N Nguyen, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Abhijit Raha, PhD, Dr. Mark J Seaton, PhD, Dr. Sriram Subramaniam, PhD, Dr. Yubing Tang, Dr. Zhou Chen (nmi), MD PhD, E Marciante, Edward O'shaughnessy, Edward Oshaughnessy, Emest F Bizjak, Emily A Walters, Emmanuel J Ramos, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Frank J Marci, Frank J Marciniak, Frank P Hurst, Fred Razzaghi, Frederick Razzaghi, Gajendiran Mahadevan, PhD, Gayle S Lawson, George Pyramides, Gianine E Tompkins, Gifford Whitehurst, Jr, Gobiga Vanniyasingam, Graeme E Price, Guerlain Ulysse, Haley H Seymour, Harperd, Hasan A Irier, PhD, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Hyojong Kwon, PhD, Iram R Hassan, PhD, Jacqueline A Shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James Norman, James R Birkenstamm, James R Fleckenstein, Jananiga Vanniyasingam, Jay B Shah, Jean Blackston Hill, Jean M Kelahan, Jean M Mulinde, MD, Jenn W Sellers, Jennifer L Custodio, Jennifer Macmillan, Jessica M Monteiro, Joan A Loreng, Jogy George, John A Sciacchitano, John L Zaccone, John P Mistler, Jonathan D Green, Jonathan G Matrisciano, Jonee J Mearns, Jose A Torres, Jose M Cayuela, Joseph F Mcginnis, RPh, Joseph L Despins, PhD, Joseph L Johnson, Joy P Matthias, Joy Rkozlowski Klena, Justine M Corson, Justine Tomasso, K Gonzlez, Kara A Scheibner, PhD, Karen E D'orazio, Karen L Kosar, Karen M Cooper, Karishma G Gopaul, Kassa Ayalew, MD, Kathleen B Swat, Keith M Reilly, Kelli F Dobilas, Kelli Regente, Kelly I Anderson, Kent A Conforti, Kerun Hardeo, Kimberly A Benson, Kimberly L Schultz, King, Kinh Q Mac, Konsuela Y Glass, Kristen C Jackson, Kristen E Rescigno, Kristy A Zielny, Kristy E Zuroski, Krystal O Ogunremi, Laishan L Lam, Larry Johnson, Lata C Mathew, PhD, Laura Fontan, MS, Lauren Iacono Connors, PhD, Lauren L Vajo, Laurie B Frazier, Lawrence R Johnson, Lenahan Lenahan, Peter R, Li Li, Liatte Kreuger, PharmD, Lily Y Koo, Linda M Hoover, Linda Thai, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Loretta Wemchik, Lori A Gioia, Luis A Dasta, M Patriciaurphy Murphy, Makini Cobourne Duval, PhD, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Maria Estrella, Marjorie D Schultz, Marshall A Naimo, Martin K You, Marvin D Jones, Mary Jeanet Mcgarry, Matther W Kyle, Matthew A Spalazo, Matthew A Spataro, Matthew C Watson, Matthew W Kyle, Maura Rooney, Mayar M Mussa, Melba T Rivera, Melba Trivera Clavell, Melissa A Freeman, Melissa A Zuppe, Melissa B Libby, Melissa T Roy, Melkamu Getie Kebtie, PhD, Meredith L Sheridan, Merril E Racke, Meyer J Slobotsky, Meyer J Sobotsky, Meyer Slobotsky, Michael P Anthony, Michael R Dominick, Michael R Klapal, Michael Skelly, Michele C Murray Schrade, Michelle A Marsh, Michelle L Johnson, Miguel G Manzano, Mihaela Jason, Mike M Rashti, Mizanne E Lewis, Mohsen Rajabi Abhari, FDA, Monica L Gutierrez, Monika Borkowska, Mpris Inspector, Msdap Gonzlezk, Myra K Casey, Namita Kothary, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Dalena, Nerizza B Guerin, Nicholas A Violand, Nicholas L Paulin, Nicola M Fenty Stewart, Niketa Patel, Nikki S Ramirez, Nimmy Mathews, Nina Yang, Niraj Mehta, Paul L Bellamy, Paul Mouris, Pearl L Gonzalez, Peter M Trunk, Peter R Lenahan, Prabhu P Raju, Pushpa S Jayasekara, Ramon E Martinez, Rebecca Rodriguez, Rebecca T Davis, Regina Regina, Regina T Brown, Remache, Richard A Abate, Richard D Manney, Richard W Berning, Robert C Steyert, Robert D Tollefsen, Robert G Ruff, Robert Sharpnack, Robert W Jennings, Robin P Mathew, Rodney T Allnutt, Rory K Geyer, Rose Ljean Mary, Russell J Glapion, Ruth A Williams, S Thomas, Sachinkumar V Patel, Sam Chan, Sandra Kershaw, Sarah Adella Fave, Sarah Forney, Satheesh Thomas, Schultz, Sherri J Liu, Shirley H Isbill, Shirley S Wen, Sidney B Priesmeyer, Simone E Pitts, Sinai Davis, Srinivas R Chennamaneni, PhD, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen C Smith, Stephen J Koniers, Stephen J Mottola, Stuart W Russell, Sunita Iyer, Sunita Pandey, Tamil Arasu, PhD, Tania E Vizcaino, Tara G Bizjak, Tara K Carmody, Tara R Gooen, Tawny L Colling, Thomas J Arista, Thomas P Hansen, Tonia F Bernard, Traci C Kelm, Tyanna N Hadley, Tynna N Hadley, Uduak M Inokon, Unnee Ranjan, Valerie C Reed, Valerie Reed, Victoria M Daddeo, Victoria Spivak, Vincent F Cafiso, Vlada Matusovsky, Wayne J Meyer, William Chang, William R Chang, Willy A Orantes, Xi Kui, cdzn, Xiaohan Cai, PhD, Xikui Chen (nmi), PhD, Xingfang Li, MD, Yangmin Ning, Yiyue Zhang (nmi), PhD, Yung W Chan, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu, Zhaohui Ye

Michael Serrano's Documents

Publish Date Document Type Title
July, 2016 FDA 483 Kourosh Asgarian, MD - Form 483, 2016-07-14
April, 2011 FDA 483 Actavis Elizabeth LLC - Form 483, 2011-04-26
August, 2023 FDA 483 Ahsan A. Abdulghani, M.D. - Form 483, 2023-08-21
January, 2016 EIR Janssen Pharmaceuticals Inc. - EIR, 2016-01-22
March, 2020 FDA 483 Elite Laboratories, Inc. - Form 483, 2020-03-13
September, 2012 EIR Syneos Health Clinical, Inc. - EIR, 2012-09-14
June, 2021 EIR Alvogen, Inc - EIR, 2021-06-10
October, 2021 EIR Mitsubishi Tanabe Pharma Development America, Inc. - EIR, 2021-10-15
September, 2021 FDA 483 Stephen S. Kasparian, MD - Form 483, 2021-09-02
July, 2014 FDA 483 Sanofi US - Form 483, 2014-07-17
October, 2021 FDA 483 Mitsubishi Tanabe Pharma Development America, Inc. - Form 483, 2021-10-15
April, 2016 FDA 483 Bristol-Myers Squibb Company - Form 483, 2016-04-27
January, 2012 EIR Bristol Myers Squibb - EIR, 2012-01-27
June, 2017 FDA 483 Rho, Inc. - Form 483, 2017-06-30
October, 2020 FDA 483 Larken Laboratories, Inc. - Form 483, 2020-10-23
November, 2016 FDA 483 Vertical Pharmaceuticals, LLC - Form 483, 2016-11-01
August, 2021 FDA 483 SK Life Science Inc. - Form 483, 2021-08-11
February, 2014 EIR inVentiv Health clinical - EIR, 2014-02-14
September, 2023 FDA 483 Teva Pharmaceuticals USA, Inc - Form 483, 2023-09-29
March, 2012 FDA 483 BRACCO DIAGNOSTICS INC - Form 483, 2012-03-08
April, 2011 EIR Actavis Elizabeth LLC - EIR, 2011-04-26
January, 2022 EIR BioClinica, Inc. - EIR, 2022-01-10
January, 2019 EIR Amerigen Pharmaceuticals Inc. - EIR, 2019-01-18
March, 2012 EIR BRACCO DIAGNOSTICS INC - EIR, 2012-03-08
May, 2015 FDA 483 Response Heritage Pharmaceuticals, Inc. - Form 483R, 2015-05-27
April, 2019 EIR Allergan, PLC. - EIR, 2019-04-11
June, 2017 EIR Rho, Inc. - EIR, 2017-06-30
November, 2021 FDA 483 Ascend Laboratories, LLC - Form 483, 2021-11-10
November, 2021 EIR Ascend Laboratories, LLC - EIR, 2021-11-10
April, 2012 FDA 483 Dr. Ahmad H. Sulaiman Dept of Psychological Medicine - Form 483, 2012-04-13
July, 2018 EIR Catalent, Inc. - EIR, 2018-07-13
January, 2018 EIR Wissam Abouzgheib, MD - EIR, 2018-01-29
January, 2014 FDA 483 St. Peter's University Hospital - CPHSR - Form 483, 2014-01-13
August, 2021 EIR SK Life Science Inc. - EIR, 2021-08-11
August, 2011 FDA 483 Access Bio, Inc. - Form 483, 2011-09-12
May, 2016 FDA 483 Bausch Health Companies, Inc. - Form 483, 2016-05-17
May, 2016 EIR Bausch Health Companies, Inc. - EIR, 2016-05-17
April, 2009 FDA 483 Johnson & Johnson Pharmaceutical Research & Development, LLC - Form 483, 2009-04-14
October, 2017 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2017-10-30
August, 2020 EIR Leading Pharma, LLC - EIR, 2020-08-11
October, 2022 FDA 483 Eugenia Girda, MD - Form 483, 2022-10-18
September, 2012 FDA 483 Syneos Health Clinical, Inc. - Form 483, 2012-09-14
October, 2015 EIR St. Peter's University Hospital - CPHSR - EIR, 2015-10-27
September, 2010 EIR Novartis Pharmaceuticals Corporation - EIR, 2010-09-03
January, 2020 FDA 483 Carlos Lastra MD - Form 483, 2020-01-13
April, 2011 FDA 483 Response Actavis Elizabeth LLC - Form 483R, 2011-06-15
June, 2019 FDA 483 Robert D. Aiken, MD - Form 483, 2019-06-26
October, 2015 FDA 483 Response St. Peter's University Hospital - CPHSR - Form 483R, 2015-10-27
June, 2021 FDA 483 Alvogen, Inc - Form 483, 2021-06-10
June, 2021 FDA 483 Bausch Health Companies, Inc. - Form 483, 2021-06-16
January, 2014 EIR St. Peter's University Hospital - CPHSR - EIR, 2014-01-13
May, 2014 EIR Merck Sharp & Dohme LLC - EIR, 2014-05-19
October, 2021 EIR Sanofi-Aventis U.S. LLC - EIR, 2021-10-01
September, 2019 EIR BioClinica Inc. - EIR, 2019-09-26
May, 2015 FDA 483 Heritage Pharmaceuticals, Inc. - Form 483, 2015-05-27
June, 2018 EIR CELGENE CORPORATION - EIR, 2018-06-27
July, 2021 EIR John L. Berk, M.D. - EIR, 2021-07-22
January, 2018 FDA 483 Steven David, M.D. - Form 483, 2018-01-08
August, 2019 FDA 483 Fresenius Medical Care Holdings, Inc. - Form 483, 2019-08-02
April, 2019 FDA 483 Response Allergan, PLC. - Form 483R, 2019-05-02
November, 2016 FDA 483 Response Vertical Pharmaceuticals, LLC - Form 483R, 2016-11-05
August, 2016 FDA 483 Sanofi US - Form 483, 2016-08-03
February, 2022 FDA 483 Nikolaos T. Pyrsopoulos, M.D. - Form 483, 2022-02-22
March, 2022 EIR CELGENE CORPORATION - EIR, 2022-03-14
July, 2016 EIR Kourosh Asgarian, MD - EIR, 2016-07-14
September, 2023 FDA 483 Vinay Sikand, M.D. - Form 483, 2023-09-21
February, 2014 FDA 483 inVentiv Health clinical - Form 483, 2014-02-14
April, 2012 EIR Dr. Ahmad H. Sulaiman Dept of Psychological Medicine - EIR, 2012-04-13
November, 2018 FDA 483 Nationwide Laboratories, LLC - Form 483, 2018-11-27
July, 2019 EIR CELGENE CORPORATION - EIR, 2019-07-26
July, 2017 EIR Labcorp Drug Development - EIR, 2017-07-26
July, 2016 FDA 483 Response Kourosh Asgarian, MD - Form 483R, 2016-07-24
April, 2019 FDA 483 Allergan, PLC. - Form 483, 2019-04-11
May, 2022 FDA 483 Dr. Reddy's Laboratories, Inc. - Form 483, 2022-05-26
February, 2019 FDA 483 St. Peter's University Hospital - CPHSR - Form 483, 2019-02-08
April, 2009 EIR Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2009-04-14
June, 2017 EIR Ranbaxy Inc. - EIR, 2017-06-20
January, 2018 FDA 483 Wissam Abouzgheib, MD - Form 483, 2018-01-29
November, 2013 FDA 483 Nephros, Inc. - Form 483, 2013-11-13
April, 2021 FDA 483 Robert S. Falcone, M.D. - Form 483, 2021-04-05
April, 2016 EIR Bristol-Myers Squibb Company - EIR, 2016-04-27
June, 2016 EIR APCER Life Sciences, Inc. - EIR, 2016-06-21
November, 2015 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2015-11-19
October, 2015 FDA 483 St. Peter's University Hospital - CPHSR - Form 483, 2015-10-27
January, 2012 FDA 483 Bristol Myers Squibb - Form 483, 2012-01-27
August, 2016 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2016-08-26
February, 2022 EIR Bristol Myers Squibb - EIR, 2022-02-02
November, 2019 FDA 483 Englewood Hospital and Medical Center IRB - Form 483, 2019-11-26
November, 2023 FDA 483 QUAGEN PHARMACEUTICALS LLC - Form 483, 2023-11-08
April, 2019 FDA 483 Allergan, PLC. - Form 483, 2019-04-11
May, 2019 FDA 483 Colgate-Palmolive Company - Form 483, 2019-07-25
September, 2020 FDA 483 Alvogen, Inc - Form 483, 2020-09-11
December, 2021 FDA 483 Robert Wood Johnson U Hosp @ Hamilton IRB - Form 483, 2021-12-22

Experience Redica Systems’ NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more