FDA Investigator Mindy M Chou

Mindy M Chou has conducted inspections on 101 sites in 6 countries as of 03 Jun 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
101
Last Inspection Date:
03 Jun 2024
Investigator Role:
FDA Investigator
Redica ID:
100004351
Countries of Inspections:
United States of America, Canada, Turkey, Taiwan, Italy, Germany
FDA Investigators that have inspected at least one site in common with Mindy M Chou:
Adena S Yau, Adetutu M Gidado, Alan L Truong, Alan P Kurtzberg, Alice S Tsao, Althea A Williams, Amatul H Marium, Anastasia M Shields, Andrew M Abramowitz, Anissa M Vargas, Anita R Michael, Anitha Palamakula Govada, Ann M Stewart, Ann Marie Montemurro, Anne Marie Russell, Annemarie Bodnar, Annet R Rajan, Arduino Frankovic, Arthur G Hurst, Ashar P Parikh, Ashley Polizzotto, Atul J Agrawal, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Benton M Ketron, Bijoy Panicker, Bo Chi, PhD, Brandon L Mariner, Brandy N Lepage, Brenda W Uratani, PhD, Brian D Nicholson, Brian J Ryan, Brooke K Higgins, Bruce G Cooper, Bryan A Galvez, Candace Y Gomez Broughton, Carl A Huffman, III, Carl A Perez, Carolyn J Cook, Caryn M Mcnab, Cassandra L Abellard, Cedar H Boakye, Charanjeet Jassal, Charisse K Green, Charles M Edwards, Christina K Theodorou, Christine A Harman, PhD, Christopher Janik, Christopher S Fields, Claire O Nicholls, Cody D Rickman, Collins, Cynthia J Lee, MS, Dana A Razzano, Daniel J Grabicki, Daniel L Zheng, David A Oluwo, David J Hafner, David L Chon, David R Delucia, Demitria J Argiropoulos, Demitria J Xiradakis, Denise L Terzian, Dennis E Guilfoyle, PhD, Diane E Bruce, Dien N Nguyen, Dipesh K Shah, Djamila Harouaka, Donald G Gordon, Donald L Lech, Dongping Dai, PhD, Dr. Robert C Horan, MD, Dr. Willie Wilson, PhD, Dr. Yubing Tang, Dr. Zhihao Qiu (Peter), PhD, Edmund F Mrak, Jr, Emest F Bizjak, Emmanuel Adu Gyamfi, PhD, Eric L Dong, BS, Eric Rothschild, Erika E Englund, PhD, Erin L Nagel, Esaw, Felix Maldonado, Frank Verni, Frank W Perrella, Gale L Glinecki, Gam S Zamil, Ganesh N Joshi, Gary J Lehr, Gary T Greco, Gregson A Joseph, Guerlain Ulysse, Gwyn G Dickinson, Harry J Brewer, Helen B Ricalde, Helen Verdel, Ifechimere I Okafor, Ilana Zigelman, Iram R Hassan, PhD, Irina Gaberman, Ivis L Negron, J Paul Kirwan, PhD, J'maica J Hunter, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Liubicich, James D Bridges, James M Mason, Jamie D Richardson, Janet A Rajan, Jason D Tenney, Jay B Shah, Jay T Wong, Jazmine N Brown, Jennifer D Hollstrom, Jens Fricke, Jesse P Hardin, Jessica L Pressley, Jie He, Joanne M Schlossin, Joel R Merriman, Jogy George, John A Podsadowski, John Dan, John M Gusto, John P Mistler, Johnna L Bleem, Johnny D Nwankwo, Jonathan G Matrisciano, Jonathan W Chapman, Jose Acruz Gonzalez, Jose M Cayuela, Jose Ohernandez Guzman, Jose R Hernandez, Joseph F Mcginnis, RPh, Joseph J Vannelli, Joseph Maselli, Joseph R Lambert, Joy Rkozlowski Klena, Juan Rjimenez Garcia, Juanita P Versace, Juliana M Badalucco, Kalavati Suvarna, PhD, Karen A Briggs, Karen L Kosar, Karishma G Gopaul, Karl Auguste, Katherine E Jacobitz, Katherine Szestypalow, Kathleen M Jordan, Kathryn A Nagy, Kellie Leveille, Kenneth G Klobus, Kenneth H Williams, Kevin A Gonzalez, Kim Lthomas Cruse, Kim M Downing, Ko U Min, Krishna Ghosh, PhD, Kristina J Donohue, Kwong P Lee, L Gnnmassimia Massimilla, PharmD, Lakshmi Narasimhan, PhD, Lata C Mathew, PhD, Laura Fontan, MS, Lauren E Blaser, Laurissa S Flowers, Lawrence W Farina, LCDR Chad N Thompson, LCDR Susan E Polifko, LCDR Wilfred A Darang, Liatte Kreuger, PharmD, Lilia L Bi, Liming Zhang, Linda M Sacco, Lisa L Flores, Lisa M Smith, LTJG Matthew R Palo, Manhar R Patel, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia D Fields, Marcus A Ray, Margaret E Sarles, Margaret L Bolte, Margaret M Sands, Maria Joselopez Barragan, PhD, Marie B Buen Bigornia, Marie Elena C Puleo, Marlene G Swider, Marlene L Davis, Mary F Finn, Mary Jeanet Mcgarry, Mary M Finn, Matthew A Spataro, Matthew D Schnittker, Maxwell Van Tassell, PhD, Melissa D Ray, Merideth K Rose, Michael A Charles, Michael E Maselli, Michael L Casner, Michael Levin, Michael R Dominick, Michael R Goga, Michael R Klapal, Michael Shanks, MS, Michael W Burd, Michelle Yclark Stuart, Mihaly S Ligmond, Milan S Mcgorty, Milos Dokmanovic, PhD, Monique Rac Lester, Mra Davism, Mra M Barbosar, Nancy A Saxenian Emmons, Nancy M Espinal, Nariman Patenaude, Natasha Gupta, Nazmul Hassan, Neal L Adams, Nealie C Newberger, Nebil A Oumer, Neil J Bonzagni, PhD MPH, Nicholas A Violand, Nicholas C Mendiola, Nicholas L Paulin, Nicole Vaught, Niketa Patel, Noreen Muñiz, Obinna R Echeozo, Ogechi C Nna, Olumide A Akinyemi, Omotunde O Osunsanmi, Ou Ma, Paige R Mccoy, Pamela L Velez Vega, Parul M Patel, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Paul E Stein, Paul L Bellamy, Paul Mouris, Paula J Bretz, Pelekakis, Penny H Mccarver, Perry T Nichols, Peter Abel, Peter Caparelli, Peter M Trunk, Peter R Caparelli, Philip F Istafanos, DMV, MS, Preston M Lee, Puspa Suresh Jayasekara, Rachael A Moliver, Rachel C Harrington, Raihan A Chowdhury, Rajiv R Srivastava, Ramon A Hernandez, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard Ferfoglia, Richard L Friedman, Richard Ledwidge (nmi), PhD, Robert C Howard, Robert C Steyert, Robert E Moncayo, Robert J Ham, Robert J Maffei, Robert J Martin, Robert J Veitch, Robin P Mathew, Rochelle K Kimmel, Rose Xu, Roseline N Boateng, Ruben C Quintana, Russ E Davis, Russell J Glapion, S Lori Brown, PhD MPH, Samina S Khan, Samir C Gala, Samuel T Walker, Sandra D Thompson, Sangeeta M Khurana, PhD, Sarah A Meehan, Sarah A Wangseng, Sarah Kennett, PhD, Satheesh Thomas, Sayyem H Akbar, Scott T Ballard, Sena G Dissmeyer, Shari L Kahn, Shirley J Berryman, Shreya Shah, Shusheen A Alexander, Sidney B Priesmeyer, Simone E Pitts, Sony Mathews, Srinivas R Chennamaneni, PhD, Sripal R Mada, PhD, Stacie A Woods, Stephen D Brown, Steven A Gonzales, Steven C Madzo, Steven J Libal, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanna E Ford, Syeda N Mahazabin, Tajah L Blackburn, Tamara L Ely, Tamara N Champion, Tamil Arasu, PhD, Tammy S Notto, Tanya R Syffrard, Tara K Carmody, Tekalign Wondimu, Terry Bridgewater, Thomas J Arista, Thomas J Mooney, Thomas P Hansen, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tiki J Dixon, Tzanko Stantchev, Uduak M Inokon, Unnee Ranjan, Valentino Fiorella, Valerie A Potopsingh, Victoria Spivak, Vioela J Caze, Viviana Matta, Vivin George, Warren J Lopicka, Wayne D Mcgrath, Wayne E Seifert, Wayne S Fortenberry, Wendy G Tan, PhD, William J Leonard, William M Rennells, Xiaokuang Lai, PhD, Xikui Chen (nmi), PhD, Yaharn Su, Young M Yoon, Yumi J Hiramine, Yuyan Liang, Yvonne M Santiago, Zakaria I Ganiyu, Zhong Li, PhD

Mindy M Chou's Documents

Publish Date Document Type Title
March, 2023 FDA 483 Delsam Pharma LLC - Form 483, 2023-03-24
June, 2018 FDA 483 Cosmetica Laboratories Inc. - Form 483, 2018-06-01
July, 2016 FDA 483 Chartwell Pharmaceuticals Amityville, LLC. - Form 483, 2016-07-15
January, 2017 FDA 483 HomeoCare Laboratories Inc. - Form 483, 2017-01-11
February, 2020 FDA 483 Holopack Verpackungstechnik GmbH - Form 483, 2020-02-18
October, 2023 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2023-10-13
December, 2018 EIR SOFIE Co. dba SOFIE - EIR, 2018-12-03
March, 2017 FDA 483 Fresenius Kabi USA, LLC - Form 483, 2017-03-30
October, 2022 FDA 483 Steri-Pharma LLC - Form 483, 2022-10-04
November, 2014 FDA 483 Ultra Seal Corporation - Form 483, 2014-11-12
May, 2021 FDA 483 Pine Pharmaceuticals, LLC - Form 483, 2021-05-14
November, 2019 EIR Catalent Maryland, Inc. - EIR, 2019-11-04
May, 2023 FDA 483 Patheon Italia S.p.A - Form 483, 2023-05-26
December, 2018 FDA 483 Nutravail LLC - Form 483, 2018-12-07
July, 2015 FDA 483 MANA PRODUCTS, INC. - Form 483, 2015-07-10
October, 2021 FDA 483 Berkshire Sterile Manufacturing, Inc. - Form 483, 2021-10-15
October, 2019 FDA 483 Regeneron Pharmaceuticals, Inc. - Form 483, 2019-10-18
March, 2017 EIR Fresenius Kabi USA, LLC - EIR, 2017-03-30
June, 2015 FDA 483 Strides Pharma, Inc - Form 483, 2015-06-04
June, 2017 FDA 483 Boothwyn Pharmacy LLC - Form 483, 2017-06-16
October, 2019 EIR Regeneron Pharmaceuticals, Inc. - EIR, 2019-10-18
May, 2019 FDA 483 Professional Disposables International, Inc. - Form 483, 2019-05-28
September, 2014 EIR P & L Development, LLC - EIR, 2014-09-17
October, 2021 EIR Berkshire Sterile Manufacturing, Inc. - EIR, 2021-10-15
October, 2015 FDA 483 Pine Pharmaceuticals, LLC - Form 483, 2015-10-09
June, 2016 FDA 483 Kings Park Slope Inc - Form 483, 2016-04-22
December, 2017 EIR NCM USA Bronx LLC - EIR, 2018-01-17
February, 2017 FDA 483 Healthy Choice Compounding LLC - Form 483, 2017-02-28
November, 2019 FDA 483 Response Catalent Maryland, Inc. - Form 483R, 2019-11-25
July, 2021 FDA 483 Reliant Compounded Solutions Monroe, LLC - Form 483, 2021-07-27
March, 2021 FDA 483 Norwich Pharmaceuticals Inc. - Form 483, 2021-03-16
November, 2017 FDA 483 BASF Corporation - Form 483, 2017-11-17
September, 2020 FDA 483 Healthy Choice Compounding LLC - Form 483, 2020-09-24
December, 2015 FDA 483 Professional Disposables International, Inc. - Form 483, 2015-12-09
December, 2019 EIR Chartwell Pharmaceuticals Carmel, LLC - EIR, 2019-12-16
March, 2019 FDA 483 NIH Clinical Center Pharmacy Department - Form 483, 2019-03-06
October, 2016 FDA 483 Cosco Enterprises, Inc - Form 483, 2016-10-27
November, 2015 FDA 483 Chartwell Pharmaceuticals Carmel, LLC - Form 483, 2015-11-02
August, 2022 FDA 483 RK PHARMA INC - Form 483, 2022-08-12
February, 2017 EIR Cerovene, Inc. - EIR, 2017-02-08
October, 2021 FDA 483 Response Berkshire Sterile Manufacturing, Inc. - Form 483R, 2021-10-15
August, 2016 EIR Amneal Pharmaceuticals of New York, LLC - EIR, 2016-08-09
April, 2021 FDA 483 J.M. Murray Center, Inc. - Form 483, 2021-04-30
December, 2019 FDA 483 Response Chartwell Pharmaceuticals Carmel, LLC - Form 483R, 2020-01-06
April, 2019 FDA 483 Hercon Pharmaceuticals LLC - Form 483, 2019-04-05
August, 2016 FDA 483 Response Syntho Pharmaceuticals Inc. - Form 483R, 2016-08-26
November, 2022 FDA 483 Advanced Accelerator Applications USA, Inc. - Form 483, 2022-11-03
September, 2022 FDA 483 ScieGen Pharmaceuticals INC - Form 483, 2022-09-02
February, 2017 FDA 483 Cerovene, Inc. - Form 483, 2017-02-08
October, 2014 FDA 483 Spa Technologies International Inc - Form 483, 2014-10-03
October, 2016 FDA 483 American Cleaning Solutions - Form 483, 2016-10-14
September, 2018 FDA 483 ULTRAtab Laboratories, Inc. - Form 483, 2018-09-14
December, 2021 EIR Aphena Pharma Solutions - Maryland, LLC - EIR, 2021-12-15
May, 2017 EIR InvaGen Pharmaceuticals, Inc - EIR, 2017-05-26
May, 2015 FDA 483 Cerovene, Inc. - Form 483, 2015-05-04
May, 2016 FDA 483 Equibal, Inc. - Form 483, 2016-05-27
November, 2022 EIR Advanced Accelerator Applications USA, Inc. - EIR, 2022-11-03
December, 2019 FDA 483 Chartwell Pharmaceuticals Carmel, LLC - Form 483, 2019-12-16
March, 2022 FDA 483 Precision Nuclear of Virginia - Form 483, 2022-03-25
December, 2018 FDA 483 Response SOFIE Co. dba SOFIE - Form 483R, 2018-12-21
December, 2018 FDA 483 SOFIE Co. dba SOFIE - Form 483, 2018-12-03
September, 2014 FDA 483 P & L Development, LLC - Form 483, 2014-09-17
January, 2019 FDA 483 Perrigo New York, Inc. - Form 483, 2019-01-22
November, 2016 EIR AMA Laboratories, Inc. - EIR, 2016-11-17
November, 2019 FDA 483 Catalent Maryland, Inc. - Form 483, 2019-11-04
August, 2016 FDA 483 Amneal Pharmaceuticals of New York, LLC - Form 483, 2016-08-09
November, 2016 FDA 483 Fougera Pharmaceuticals Inc. - Form 483, 2016-11-10
May, 2017 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2017-05-26
November, 2015 EIR Chartwell Pharmaceuticals Carmel, LLC - EIR, 2015-11-02
February, 2022 FDA 483 WES PHARMA INC - Form 483, 2022-02-18
December, 2021 FDA 483 Aphena Pharma Solutions - Maryland, LLC - Form 483, 2021-12-15
March, 2015 EIR InvaGen Pharmaceuticals, Inc - EIR, 2015-03-13
August, 2014 FDA 483 POLYGEN PHARMACEUTICALS INC. - Form 483, 2014-08-29
January, 2022 FDA 483 Zennova LLC - Form 483, 2022-01-27
May, 2022 FDA 483 Akorn Operating Company LLC (dba Akorn) - Form 483, 2022-05-17
August, 2019 FDA 483 SSM Health Care St. Louis DBA SSM St. Clare Health Center - Form 483, 2019-08-28
July, 2016 FDA 483 Grace, William R M.D. - Form 483, 2016-07-08
March, 2015 FDA 483 InvaGen Pharmaceuticals, Inc - Form 483, 2015-03-13
August, 2016 FDA 483 Syntho Pharmaceuticals Inc. - Form 483, 2016-08-26
August, 2015 FDA 483 The Estee Lauder Inc - Form 483, 2015-08-06
December, 2016 FDA 483 Magellan Rx Pharmacy, LLC - Form 483, 2016-12-22
January, 2017 FDA 483 Response HomeoCare Laboratories Inc. - Form 483R, 2017-03-01
September, 2018 EIR ULTRAtab Laboratories, Inc. - EIR, 2018-09-14
May, 2024 FDA 483 United Therapeutics Corporation - Form 483, 2024-05-02
November, 2022 FDA 483 Response Advanced Accelerator Applications USA, Inc. - Form 483R, 2022-11-03
December, 2017 FDA 483 NCM USA Bronx LLC - Form 483, 2017-12-08

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