FDA Investigator Shirley S Wen

Shirley S Wen has inspections in 5 countries as of 26 Oct 2023. Shirley S Wen has collaborated with a combinined 3287 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
84
Last Inspection Date:
26 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
Country:
United States of America, Italy, Romania, Germany, Turkey
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Allen Lou, Amy Franklin, Amy L Singer, Amy Lynn Frankshun, PhD, Anastasia I Offordile, Annemarie Bodnar, Annet R Rajan, Anthony J Donato, Anthony M Criscuolo, Jr, Arie C Menachem, Atul J Agrawal, Barbara D Wright, Barbara J Maulfair, Barbara Jwilimczyk Macri, Bei Yu, Bo Chi, PhD, Bogdan Kurtyka, Brenda P King, Byungja E Marciante, Byungja E Mercuente, Byungja H Marciante, Camerson E Moore, Cary Greene, Celia N Cruz, Charlotte Hinkle, Charlotte P Chang, Cheryl J Legrand, Chiang Syin, PhD, Christina Capacci Daniel, PhD, Christina P Burkhart, Christine M Cerenzio, Craig T Rybus, Cynthia F Kleppinger, MD, Cynthia Jim, CSO, Cynthia Whitmarsh, Daniel J Grabicki, Darin S Wiegers, David A Oluwo, Dawa L Wydner, Dawn C Olenjack, Dawn L Wydner, Dawn L Wyndver, Deborah B Nixon, Denise M Visco, Investigator, Denise M Visu, Dhaval H Patel, Donald L Lech, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Douglas Florentino, Dr. Abhijit Raha, PhD, Dr. Robert C Horan, MD, Edmund F Mrak, Jr, Emest F Bizjak, Eric Rothschild, Erik W Koester, Erin D Mccaffery, Frank J Marciniak, Frederick Razzaghi, Gary J Hagan, Gianine E Delade, Guerlain Ulysse, Helen Verdel, Herrmann, Himanshu Gupta, PhD, Hitesh R Patel, Janet A Rajan, Jason Kwong, Jean M Kelahan, Jean M Mulinde, MD, Jogy George, John P Mistler, Jonathan G Matrisciano, Jonee J Mearns, Jose Acruz Gonzalez, Joseph L Despins, PhD, Joy Rkozlowski Klena, Judith A Jones, Junho Pak, Justin A Boyd, Justine M Corson, Justine Tomasso, Karen E D'orazio, Karen F Tomaziefski, Karen M Cooper, Karishma G Gopaul, Keith M Reilly, Kelli F Dobilas, Kelly I Anderson, Kenneth H Williams, Kerry A Kurdilla, King, Kinh Q Mac, Ko U Min, Kristen E Rescigno, Kristy A Zielny, Krystal O Ogunremi, Kwong P Lee, Kyle D Covill, Laishan L Lam, Lata C Mathew, PhD, Lauren L Vajo, LCDR Debra Emerson, LCDR Wilfred A Darang, Li Li, Li Yun Huang, Lisa Mathew, Loretta Nemchik, Loretta Wemchik, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Mariza M Jafary, Mathew T Thomas, MD, Matthew C Watson, Megan A Haggerty, Melissa A Freeman, Melissa T Roy, Melkamu Getie Kebtie, PhD, Meredith L Sheridan, Meyer J Slobotsky, Meyer J Sobotsky, Michael Rosner, Michael Serrano, Michelle A Marsh, Mihaly S Ligmond, Mike M Rashti, Mpris Inspector, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nancy Sheraga, Nerizza B Dalena, Nerizza B Guerin, Nicholas A Violand, Nina Yang, Pamela L Ogonowski, Paraluman S Leonin, Patrick C Klotzbuecher, Paul L Bellamy, Peter R Lenahan, Prabhu P Raju, Raymond L Cheung, Regina Regina, Regina T Brown, Remache, Richard A Abate, Richard D Manney, Robert J Martin, Robert Mo Brien, Robert W Mccullough, Rodrigo Vilchez, Rory K Geyer, Rose Ljean Mary, Russell J Glapion, Saleem A Akhtar, Samina S Khan, Sandra A Boyd, Sandra Kershaw, Sandra P White, Sean R Marcsisin, Sena G Dissmeyer, Seng Ching Hwang, Sharmista Chatterjee, Sherri J Liu, Simone E Pitts, Srinivas R Chennamaneni, PhD, Stacey S Degarmo, State Agency, Stephen J Mottola, Tara K Carmody, Thomas J Arista, Tressa T Lewis, Tyanna N Hadley, Unnee Ranjan, Valerie C Reed, Vioela J Caze, William R Chang, Willy A Orantes, Xi Kui, cdzn, Xikui Chen (nmi), PhD, Xingfang Li, MD, Yong Hu, Yvesna C Blaise, Ze Peng

Shirley S Wen's Documents

Publish Date Document Type Title
October, 2021 FDA 483 Aquestive Therapeutics Inc. - Form 483, 2021-10-07
April, 2020 EIR Bristol Myers Squibb - EIR, 2020-04-22
July, 2019 FDA 483 Novartis Pharmaceuticals Corporation - Form 483, 2019-07-02
August, 2021 FDA 483 Response Fosun Pharma USA Inc. - Form 483R, 2021-09-07
April, 2019 FDA 483 FOAMIX PHARMACEUTICALS, INC. - Form 483, 2019-04-24
November, 2019 FDA 483 Validus Pharmaceuticals, Inc. - Form 483, 2019-11-13
September, 2019 EIR Daniel P. Petrylak, M.D. - EIR, 2019-09-20
February, 2018 FDA 483 Braeburn Pharmaceuticals Inc. - Form 483, 2018-02-08
September, 2020 FDA 483 Bi-Coastal Pharma International - Form 483, 2020-09-14
May, 2022 EIR BioClinica, Inc. - EIR, 2022-05-12
September, 2017 EIR David R. Hassman, DO - EIR, 2017-09-27
August, 2021 FDA 483 Fosun Pharma USA Inc. - Form 483, 2021-08-17
February, 2018 EIR Braeburn Pharmaceuticals Inc. - EIR, 2018-02-08
October, 2021 EIR Aquestive Therapeutics Inc. - EIR, 2021-10-07
October, 2017 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2017-10-30
August, 2021 EIR Fosun Pharma USA Inc. - EIR, 2021-08-17
October, 2018 EIR Sanofi-Aventis U.S. LLC - EIR, 2018-10-09
February, 2021 EIR BioClinica, Inc. - EIR, 2021-02-05
February, 2019 EIR Janssen Research & Development, LLC - EIR, 2019-02-04
March, 2019 FDA 483 Bristol-Myers Squibb Company - Form 483, 2019-03-07
August, 2016 FDA 483 Sanofi US - Form 483, 2016-08-03
June, 2020 EIR Brightech International LLC - EIR, 2020-06-19
June, 2019 EIR ALLERGAN SALES, LLC - EIR, 2019-06-06
June, 2016 EIR APCER Life Sciences, Inc. - EIR, 2016-06-21
August, 2016 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2016-08-26
May, 2023 FDA 483 Sterigenics US LLC - Form 483, 2023-05-31

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