FDA Investigator Michael Serrano

Michael Serrano has conducted inspections on 257 sites in 13 countries as of 17 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:

257

Last Inspection Date:

17 Jun 2024

Investigator Role:

FDA Investigator

Redica ID:

100008944

Countries of Inspections:

United States of America, Japan, New Zealand, India, France, Taiwan, Canada, Malaysia, Ethiopia, Thailand, Philippines, Cayman Islands, Korea (Republic of)

FDA Investigators that have inspected at least one site in common with Michael Serrano:

Addam S Reynolds, Adetutu M Gidado, Alan R Condon, Alberto A Viciedo, Alice S Tsao, Alicia A Dalley, Allen Lou, Althea A Williams, Amanda E Lewin, PhD, Amatul H Marium, Amit Kokate, Amy A Johnson, Amy Franklin, Amy L Singer, Amy Lynn Frankshun, PhD, Amy M Codella, Amy M Cramer, Ana S Cabrera, Anastasia I Offordile, Andrew R Wasko, Ankur C Patel, Ann Marie Montemurro, Anna R Kwilas, Annemarie Bodnar, Annet R Rajan, Anthony J Donato, Arie C Menachem, Arindam Dasgupta, PhD, Ashley J Burns, Asia D Clark, Atul J Agrawal, Barbara D Wright, Barbara J Maulfair, Barbara Jwilimczyk Macri, Barbara L Rellahan, PhD, Bei Yu, Betsy C Galliher, Byungja E Marciante, Cara M Minelli, Carmen Y Fisher, 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, 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, Dawn C Olenjack, Dawn L Wydner, Deborah B Nixon, Debra A Taylor, Debra Lboyd Seale, Demitria J Argiropoulos, Demitria J Xiradakis, Denise M Visco, Investigator, Denise M Visu, Diane B Radice, Dien N Nguyen, Dolores Harper, 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, Edward O'shaughnessy, Emest F Bizjak, Emily A Baldwin, Emily A Walters, Emmanuel Jramos Maldonado, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Frank J Marciniak, Frank P Hurst, Fred Razzaghi, Frederick F 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, Hasan A Irier, PhD, Helen B Ricalde, Helen Verdel, Himanshu Gupta, PhD, Hugh M Mcclure, II, Hyojong Kwon, PhD, Iram R Hassan, PhD, Jacqueline A O'shaughnessy, PhD, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James Norman, James R Birkenstamm, James R Fleckenstein, Jananiga Vanniyasingam, Janet A Rajan, Jay B Shah, Jean Blackston Hill, Jean M Kelahan, Jean M Mulinde, MD, Jenn W Sellers, Jennifer L Custodio, Jennifer Macmillan, Jenny Sung, 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, Jose Ohernandez Guzman, Joseph F Mcginnis, RPh, Joseph L Despins, PhD, Joseph L Johnson, Joy P Matthias, Joy Rkozlowski Klena, Juanita P Versace, 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, 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, Laurel A Beer, 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, Lori A Gioia, Luis A Dasta, 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 Yau, PhD, Marvin D Jones, Mary Jeanet Mcgarry, Masfin Abdi, Matthew A Spataro, Matthew C Watson, Matthew W Kyle, Maura Rooney, Mayar M Mussa, 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, Michael F Skelly, PhD, Michael P Anthony, Michael R Dominick, Michael R Klapal, Michael Skelly, Michele C Murray Schrade, Michelle A Marsh, Michelle L Johnson, Miguel Gmanzano Maldonado, Mihaela Jason, Mike M Rashti, Mizanne E Lewis, Mohsen Rajabi Abhari, FDA, Monica L Gutierrez, Monika Borkowska, 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 R Mehta, PhD, Paul L Bellamy, Paul Mouris, Pearl L Gonzalez, Peter M Trunk, Peter R Lenahan, Prabhu P Raju, Puspa Suresh Jayasekara, Ramon E Martinez, Rebecca Rodriguez, Rebecca T Davis, Regina T Brown, Remache, Richard A Abate, Richard D Manney, Richard M Fejka, Richard W Berning, Robert C Steyert, Robert D Tollefsen, Robert G Ruff, Robert Jennings, Robert Sharpnack, Robin P Mathew, Rodney T Allnutt, Rory K Geyer, Rose Ljean Mary, Russell J Glapion, Ruth A Williams, Sachinkumar V Patel, Sam Chan, Samir C Gala, 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 I Davis, Spiridoula Dimopoulos, Srinivas R Chennamaneni, PhD, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen C Smith, Stephen J Koniers, Stephen J Mottola, Stephenie M Ortiz, Stuart W Russell, Suchan Kim, Sunita Iyer, Sunita Pandey, Tamil Arasu, PhD, Tania E Vizcaino, Tara G Bizjak, Tara K Carmody, Tara R Gooen, Tawny L Colling, Thai D Truong, Thomas J Arista, Thomas P Hansen, Tonia F Bernard, Traci C Kelm, Tyanna 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 R Chang, Willy A Orantes, 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
June, 2017	EIR	Rho, Inc. - EIR, 2017-06-30
May, 2022	FDA 483	Dr. Reddy's Laboratories, Inc. - Form 483, 2022-05-26
October, 2015	EIR	St. Peter's University Hospital - CPHSR - EIR, 2015-10-27
November, 2015	FDA 483	Merck Sharp & Dohme LLC - Form 483, 2015-11-19
November, 2021	FDA 483	Ascend Laboratories, LLC - Form 483, 2021-11-10
March, 2022	EIR	CELGENE CORPORATION - EIR, 2022-03-14
February, 2014	FDA 483	inVentiv Health clinical - Form 483, 2014-02-14
November, 2021	EIR	Ascend Laboratories, LLC - EIR, 2021-11-10
April, 2019	EIR	Allergan, PLC. - EIR, 2019-04-11
February, 2019	FDA 483	St. Peter's University Hospital - CPHSR - Form 483, 2019-02-08
April, 2009	FDA 483	Johnson & Johnson Pharmaceutical Research & Development, LLC - Form 483, 2009-04-14
June, 2018	EIR	CELGENE CORPORATION - EIR, 2018-06-27
September, 2020	FDA 483	Alvogen, Inc - Form 483, 2020-09-11
January, 2020	FDA 483	Carlos Lastra MD - Form 483, 2020-01-13
August, 2020	EIR	LEADING PHARMA, LLC - EIR, 2020-08-11
January, 2016	EIR	Janssen Pharmaceuticals Inc. - EIR, 2016-01-22
August, 2011	FDA 483	Access Bio, Inc. - Form 483, 2011-09-12
January, 2014	FDA 483	St. Peter's University Hospital - CPHSR - Form 483, 2014-01-13
April, 2012	EIR	Dr. Ahmad H. Sulaiman Dept of Psychological Medicine - EIR, 2012-04-13
July, 2016	EIR	Kourosh Asgarian, MD - EIR, 2016-07-14
March, 2024	FDA 483	Tris Pharma Inc - Form 483, 2024-03-08
August, 2019	FDA 483	Fresenius Medical Care Holdings, Inc. - Form 483, 2019-08-02
September, 2023	FDA 483	Vinay Sikand, M.D. - Form 483, 2023-09-21
September, 2010	EIR	Novartis Pharmaceuticals Corporation - EIR, 2010-09-03
April, 2011	FDA 483	Actavis Elizabeth LLC - Form 483, 2011-04-26
September, 2012	FDA 483	Syneos Health Clinical, Inc. - Form 483, 2012-09-14
July, 2019	EIR	CELGENE CORPORATION - EIR, 2019-07-26
October, 2020	FDA 483	Larken Laboratories, Inc. - Form 483, 2020-10-23
January, 2019	EIR	Amerigen Pharmaceuticals Inc. - EIR, 2019-01-18
June, 2017	FDA 483	Rho, Inc. - Form 483, 2017-06-30
January, 2022	EIR	BioClinica, Inc. - EIR, 2022-01-10
November, 2016	FDA 483	Vertical Pharmaceuticals, LLC - Form 483, 2016-11-01
April, 2011	FDA 483 Response	Actavis Elizabeth LLC - Form 483R, 2011-06-15
April, 2012	FDA 483	Dr. Ahmad H. Sulaiman Dept of Psychological Medicine - Form 483, 2012-04-13
March, 2012	FDA 483	BRACCO DIAGNOSTICS INC - Form 483, 2012-03-08
April, 2011	EIR	Actavis Elizabeth LLC - EIR, 2011-04-26
March, 2012	EIR	BRACCO DIAGNOSTICS INC - EIR, 2012-03-08
January, 2018	FDA 483	Steven David, M.D. - Form 483, 2018-01-08
February, 2014	EIR	inVentiv Health clinical - EIR, 2014-02-14
September, 2023	FDA 483	Teva Pharmaceuticals USA, Inc - Form 483, 2023-09-29
October, 2017	FDA 483	Merck Sharp & Dohme LLC - Form 483, 2017-10-30
July, 2018	EIR	Catalent, Inc. - EIR, 2018-07-13
January, 2018	EIR	Wissam Abouzgheib, MD - EIR, 2018-01-29
May, 2016	FDA 483	Bausch Health Companies, Inc. - Form 483, 2016-05-17
June, 2019	FDA 483	Robert D. Aiken, MD - Form 483, 2019-06-26
June, 2021	FDA 483	Alvogen, Inc - Form 483, 2021-06-10
January, 2014	EIR	St. Peter's University Hospital - CPHSR - EIR, 2014-01-13
November, 2023	FDA 483	QUAGEN PHARMACEUTICALS LLC - Form 483, 2023-11-08
May, 2016	EIR	Bausch Health Companies, Inc. - EIR, 2016-05-17
November, 2018	FDA 483	Nationwide Laboratories, LLC - Form 483, 2018-11-27
October, 2015	FDA 483 Response	St. Peter's University Hospital - CPHSR - Form 483R, 2015-10-27
June, 2021	FDA 483	Bausch Health Companies, Inc. - Form 483, 2021-06-16
August, 2021	EIR	SK Life Science Inc. - EIR, 2021-08-11
January, 2018	FDA 483	Wissam Abouzgheib, MD - Form 483, 2018-01-29
May, 2019	FDA 483	Colgate-Palmolive Company - Form 483, 2019-07-25
August, 2016	FDA 483	Sanofi US - Form 483, 2016-08-03
June, 2017	EIR	Ranbaxy Inc. - EIR, 2017-06-20
April, 2021	FDA 483	Robert S. Falcone, M.D. - Form 483, 2021-04-05
August, 2021	FDA 483	SK Life Science Inc. - Form 483, 2021-08-11
May, 2015	FDA 483	Heritage Pharmaceuticals, Inc. - Form 483, 2015-05-27
February, 2022	EIR	Bristol Myers Squibb - EIR, 2022-02-02
June, 2021	EIR	Alvogen, Inc - EIR, 2021-06-10
September, 2012	EIR	Syneos Health Clinical, Inc. - EIR, 2012-09-14
April, 2016	FDA 483	Bristol-Myers Squibb Company - Form 483, 2016-04-27
October, 2021	FDA 483	Mitsubishi Tanabe Pharma Development America, Inc. - Form 483, 2021-10-15
August, 2016	FDA 483	Merck Sharp & Dohme LLC - Form 483, 2016-08-26
October, 2021	EIR	Sanofi-Aventis U.S. LLC - EIR, 2021-10-01
August, 2023	FDA 483	Ahsan A. Abdulghani, M.D. - Form 483, 2023-08-21
May, 2015	FDA 483 Response	Heritage Pharmaceuticals, Inc. - Form 483R, 2015-05-27
April, 2019	FDA 483	Allergan, PLC. - Form 483, 2019-04-11
July, 2021	EIR	John L. Berk, M.D. - EIR, 2021-07-22
December, 2021	FDA 483	Robert Wood Johnson U Hosp @ Hamilton IRB - Form 483, 2021-12-22
March, 2020	FDA 483	Elite Laboratories, Inc. - Form 483, 2020-03-13
June, 2016	EIR	APCER Life Sciences, Inc. - EIR, 2016-06-21
April, 2019	FDA 483 Response	Allergan, PLC. - Form 483R, 2019-05-02
January, 2012	FDA 483	Bristol Myers Squibb - Form 483, 2012-01-27
October, 2015	FDA 483	St. Peter's University Hospital - CPHSR - Form 483, 2015-10-27
November, 2019	FDA 483	Englewood Hospital and Medical Center IRB - Form 483, 2019-11-26
October, 2022	FDA 483	Eugenia Girda, MD - Form 483, 2022-10-18
September, 2021	FDA 483	Stephen S. Kasparian, MD - Form 483, 2021-09-02
July, 2017	EIR	Labcorp Drug Development - EIR, 2017-07-26
January, 2019	FDA 483	RISING PHARMACEUTICALS INC - Form 483, 2019-01-28
April, 2009	EIR	Johnson & Johnson Pharmaceutical Research & Development, LLC - EIR, 2009-04-14
July, 2016	FDA 483	Kourosh Asgarian, MD - Form 483, 2016-07-14
October, 2021	EIR	Mitsubishi Tanabe Pharma Development America, Inc. - EIR, 2021-10-15
November, 2013	FDA 483	Nephros, Inc. - Form 483, 2013-11-13
November, 2016	FDA 483 Response	Vertical Pharmaceuticals, LLC - Form 483R, 2016-11-05
January, 2012	EIR	Bristol Myers Squibb - EIR, 2012-01-27
April, 2016	EIR	Bristol-Myers Squibb Company - EIR, 2016-04-27
July, 2014	FDA 483	Sanofi US - Form 483, 2014-07-17
September, 2019	EIR	BioClinica Inc. - EIR, 2019-09-26
February, 2022	FDA 483	Nikolaos T. Pyrsopoulos, M.D. - Form 483, 2022-02-22
July, 2016	FDA 483 Response	Kourosh Asgarian, MD - Form 483R, 2016-07-24
March, 2019	FDA 483	Navinta LLC - Form 483, 2019-03-28
May, 2014	EIR	Merck Sharp & Dohme LLC - EIR, 2014-05-19
February, 2024	FDA 483	Dipakkumar P. Pandya, M.D. - Form 483, 2024-02-01
November, 2021	EIR	Ascend Laboratories, LLC - EIR, 2021-12-17
February, 2024	FDA 483	Dipakkumar P. Pandya, M.D. - Form 483, 2024-02-01
September, 2017	EIR	Xenobiotic Laboratories, Inc. - EIR, 2017-09-15
August, 2024	FDA 483	Intervet Inc. (d/b/a Merck Animal Health) - Form 483, 2024-08-06

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