FDA Investigator Michael Serrano

Michael Serrano has inspections in 12 countries as of 13 Dec 2023. 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:
13 Dec 2023
Investigator Role:
FDA Investigator
Redica ID:
100008944
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

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