FDA Investigator Julianne C Mccullough

Julianne C Mccullough has conducted inspections on 223 sites in 10 countries as of 19 Sep 2019. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
223
Last Inspection Date:
19 Sep 2019
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, United Kingdom of Great Britain and Northern Ireland, France, Singapore, Germany, India, Italy, Australia, Portugal, Belgium
FDA Investigators that have inspected at least one site in common with Julianne C Mccullough:
Abdellah El Hajjam, Adetutu M Gidado, Alan D Centi, Albert A Salvador, Alison N Correll, Alla Kachko, PhD, Amanda M Osteen, Anastasia G Lolas, Anastasia I Offordile, Anastasia I Onuorah, Anastasia M Shields, Angela E Glenn, Anissa M Cheung, Anita Narula, PhD, Anita R Michael, Ann L Demarco, Ann Marie Karnick, Ann Marie Montemurro, Ann Marie Schofield, Anne E Johnson, Anthony A Charity, Audrey Thereset Uy, Barbara A Gullick, Barbara I Rogolsky, Ben Du, Bernice F Hirsch, Bijoy Panicker, Bo Chi, PhD, Brandi L Garbutt, Brandon J Brookens, Brandy N Lepage, Brentley S Collins, Brian D Young, Brian S Keefer, Calvin W Edwards, Cara M Minelli, Carol L Rehkopf, Caryn M Mcnab, CDR Jeremy L Wally, PhD, CDR Michael J Mero, Celia L Hutchinstein, Chao Ming Tsai, Charles M Edwards, Charles R Cote, RIC, Cheryl A Clausen, Chiang Syin, PhD, Christian D Lynch (CDL), Christina J Sauder, PhD, Christina K Theodorou, Christina Theodorou, Christopher J Adams, Christopher S Keating, Christopher T Peters, Clifton L Randell, Colleen M Damon, Concepcion Cruz, Jr, Craig D Zagata, Crayton Lee, Crystal A Harlan, Cynthia A Palmer, Cynthia Jim, CSO, Cynthia White, Dandan Wang, PhD, Daniel J Grabicki, Daniel J Mechenbier, Daniel T Lee, Daniel W Johnson, Darlene C Plank Turlington, Dauksism, Dave Hafner, David A Oluwo, David A Schwartz, David J Hafner, David K Lau, David L Pearce, David M Beltran, Dawn D Aiello, Deborah G Haney Cozzone, Debra J Bennett, Debra L Pagano, Denise M Digiulio, Dennis Cantellops Paite, Derek S Dealy, Devaughn Edwards, Donald W Myrick, Donyel M Jones, Dr. Barbara D Paul, PhD, Dr. Mark J Seaton, PhD, Dr. Ralph M Bernstein, PhD, Edward D Mcdonald, Edwin L Hobbs, Edwin Melendez, Eileen A Liu, Ellen Huang, Emily A Walters, Eric S Myskowski, Erika M Wilkerson, Erika V Butler, Evan Tong, Frank W Perrella, Gam S Zamil, Gayle S Lawson, Gene D Arcy, George J Flynn, George Pyramides, Gerald B Seaborn, Jr, Gerald W Kopp, Gianine E Delade, Gianine E Tompkins, Gillian B Nardelli, Giovanni A Vigilante, Grace I Cortesini, H Ljamilla Selby, Haitao Li, Hala L Selby, Hala Lj Whetstone, Haruhiko Murata, Hector A Carrero, Helen B Ricalde, Helen Verdel, Heriberto Negron Rivera, Howard B Rabinovitch, J David Doleski, Jacob M Dyer, Jacqueline Mdiaz Albertini, Jaison J Eapen, James C Illuminati, James M Mason, James M Odonnell, James P Mcevoy, Janet L Bowen, Jean Blackston Hill, Jeannie R Mayberry, Jeen S Min, Jeffery A Hangartner, Jeffrey P Raimondi, Jessica M Monteiro, Joan A Loreng, Joan Adamo, Joanne E King, Joanne Heim, Joanne M Hajoway, Jogy George, John D Jaworski, Jose Acruz Gonzalez, José E Meléndez, Jose M Cayuela, Jose Velez, Joseph Brady, Joseph George, Joseph L Despins, PhD, Joseph S Fanelli, Joseph T Dougherty, Joshua C Schafer, Juanita P Versace, Judith A Paterson, Julie M Anbarchian, Junho Pak, Justin A Boyd, Justin B Holder, Kalavati Suvarna, PhD, Karen A Briggs, Karyn M Campbell, Katherine E Jacobitz, Katherine Szestypalow, Kathleen B Mihalik, Kathryn Carbone, MD, Kelly N Kerr, Kendra L Brooks, Kenneth H Williams, Kenneth M Gordon, Kham Phommachanh, Kim G Campbell, Kimberly A Dux, Kish Bolden, Ko U Min, Kristen D Evans, Kristina J Donohue, Kristina L Conroy, Kristina Mjoyce Pittman, Kurt A Brorson, PhD, Kyle D Covill, Kyle S Hobson, Lakshmi Narasimhan, PhD, Lance Mde Souza, MBA, Latorie S Jones, LCDR Margaret Edi Gennaro, LCDR Susan E Polifko, Linda M Hoover, Linda M Ross, Linda S Mattingly, Linda Thai, Lisa B Orr, Lisa M Bellows, Lisa M Feola, Lori A Rose, LT John M Mastalski, LTJG Bradley E Benasutti, LTJG Lauren N Shade, Luella J Rossi, Luis A Dasta, Luis Mburgos Medero, Magda M Karlsen, Magdi Ali, Marc A Jackson, Jr, Marcelo O Mangalindan, Jr, Marea K Harmon, Maria A Reed, Maria Estrella, Marian E Major, PhD, Marie B Buen Bigornia, Marion Michaelis, Martha Sullivan Myrick, Mary E Farbman, PhD, Marybet Lopez Negron, Matthew M Henciak, Matthew R Dionne, Matthew R Noonan, Maureen A Duckworth, Maureen A Wentzel, Meena Bansal Gupta, PhD, Megan A Haggerty, Megan F Mclaughlin, Megan M Lauff, Melissa J Garcia, Melissa M Dauksis, Meredith L Sheridan, Michael A Charles, Michael A Taylor, Michael Curbarg, Michael D Omeara, Michael Gurbarg, Michael J Nerz, Michael L Casner, Michael R Goga, Michael R Klapal, Michael Rosner, Michele Gottshall, Michele M Falchek, Michele Perry Williams, Miguel A Martinez Perez, Mihaly S Ligmond, Mike M Rashti, Monika Borkowska, Morris Paul, Mra Mcculloughj, Mra Narulaa, Muralidhara B Gavini, PhD, Murthy Vkn Sikha, Myrick, Nancy L Rose, Nebil A Oumer, Nicholas A Violand, Nicole E Knowlton, Nikisha M Bolden, Noreen Muñiz, Oleg Vesnovsky, Omotunde O Osunsanmi, Pamela M Tremarki, Parul M Patel, Patricia F Hughes, PhD, Patrick C Klotzbuecher, Patrick L Wisor, Patty P Kaewussdangkul, Paul A Bonneau, Paul L Bellamy, Paula A Trost, Paula M Laplant, Peter E Baker, Philip F Istafanos, DMV, MS, Phillip M Pontikos, Prabhu P Raju, Princess R Campbell, Rabin N Ghoshal, Rachael O Oyewole, Raffi B Papazian, Rajiv R Srivastava, Ralph A Erickson, Ralph H Vocque, Ramanda C Gregory, Ramon E Martinez, Raymond L Cheung, Rebecca K Olin, Regina T Brown, Reyes Candau Chacon, PhD, Rita F Larocca Mahoney, Robert B Shibuya, MD, Robert C Coleman, Robert D Tollefsen, Robert G Ruff, Robert J Maffei, Robert J Martin, Robert Maffei, Rochelle K Kimmel, Ronald A Stokes, Ronald T Colucci, Rose Ashley, Rozelle G Smith, Ruben C Quintana, Russell J Glapion, Russell P Vandermark, Ruth A Oni, S Lori Brown, PhD MPH, Saleem A Akhtar, Sam Pepe, Sandra A Hughes, Sangeeta M Khurana, PhD, Santos E Camara, Sarah K Lemin, Scott E Norris, Sean D Duke, Seneca D Toms, Seng Ching Hwang, Sharon K Thoma, PharmD, Sheila Dreher Lesnick, Shelley L Waring, Shirley J Berryman, Shuang Tang, Sidney B Priesmeyer, Simone E Pitts, Stephanie Mangigian, MS/OSH, RN, Stephen D Brown, Stephen J Koniers, Steven A Rubin, Steven D Kehoe, Steven E Kane, Steven L Carter, Steven P Donald, Subramanian Muthukkumar, PhD, Susan F Laska, MS, Susan M Jackson, Susan T Hadman, Susanna E Ford, Susanne M Richardson, MS RAC, Syeda N Mahazabin, Tamara J Umscheid, Tammy L Chavis, Tania E Vizcaino, Ted L Anderson, Tekalign Wondimu, Temar Q Williams, Thai D Truong, Thomas E Friel, Thomas R Withers, Tiffani D Wilson, Timothy J Schmidt, Timothy T Kapsala, Tina S Roecklein, Todd J Maushart, Tonya O Corbin, Toyin B Oladimeji, Tracy Denison, PhD, Travis R Hunt, Van Cliff, Vani Mathur Richards, Vivin George, Vlada Matusovsky, Wayne E Seifert, Wayne T Smith, Wei Wang, PhD, Wenzheng Wendy Zhang, Whitney S Reynolds, William C Brenneman, Xiao Wang, Xiaokuang Lai, PhD, Xinyi Hui, Yangmin Ning, Yessika Mashinski, Yvesna C Blaise, Yvonne C Mcknight, Yvonne C Wood, Zachary L Miller, Zhong Li, PhD

Julianne C Mccullough's Documents

Publish Date Document Type Title
January, 2008 FDA 483 PEL HEALTHCARE LLC - Form 483, 2008-01-30
August, 2009 FDA 483 Vertellus Health & Specialty Products LLC - Form 483, 2009-08-19
September, 2011 FDA 483 Steriscience Specialties Private Limited - Form 483, 2011-09-29
January, 2008 EIR PEL HEALTHCARE LLC - EIR, 2008-01-30
August, 2010 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2010-08-18
October, 2009 FDA 483 APOZEAL PHARMACEUTICALS INC - Form 483, 2009-10-27
June, 2012 FDA 483 Janssen Biotech, Inc. - Form 483, 2012-06-15
June, 2013 FDA 483 Response PEL HEALTHCARE LLC - Form 483R, 2013-06-24
June, 2015 FDA 483 Almac Pharma Services LLC - Form 483, 2015-06-25
December, 2012 FDA 483 Summers Laboratories Inc - Form 483, 2012-12-28
June, 2013 FDA 483 PEL HEALTHCARE LLC - Form 483, 2013-06-05
September, 2011 FDA 483 Ipca Laboratories Limited - Form 483, 2011-09-19
April, 2010 FDA 483 PEL HEALTHCARE LLC - Form 483, 2010-04-28
June, 2012 EIR Janssen Biotech, Inc. - EIR, 2012-06-15
January, 2010 FDA 483 Laboratory Testing Inc. - Form 483, 2010-01-08
August, 2011 FDA 483 Merck Sharp & Dohme LLC - Form 483, 2011-08-11
March, 2012 EIR Johnson Matthey Inc. - EIR, 2012-03-27
January, 2012 FDA 483 Frontida BioPharm, LLC - Form 483, 2012-01-27
July, 2012 EIR Auxilium Pharmaceuticals, LLC - EIR, 2012-07-06
September, 2012 FDA 483 High Chemical Company, Div of National Generic Distributors - Form 483, 2012-09-07
April, 2013 EIR Pentec Health - EIR, 2013-04-01
January, 2008 FDA 483 Response PEL HEALTHCARE LLC - Form 483R, 2008-02-15
February, 2010 EIR Johnson & Johnson Consumer Inc. - EIR, 2010-02-02
March, 2009 FDA 483 Cipla Ltd. - Form 483, 2009-03-26
July, 2012 FDA 483 Auxilium Pharmaceuticals, LLC - Form 483, 2012-07-06
February, 2011 FDA 483 Genus Lifesciences Inc. - Form 483, 2011-02-03
May, 2009 FDA 483 Accupac, LLC - Form 483, 2009-06-26
March, 2012 FDA 483 Johnson Matthey Inc. - Form 483, 2012-03-29
June, 2009 EIR Frontida BioPharm, LLC - EIR, 2009-06-30
October, 2009 FDA 483 Delvco Pharma Packaging Services, Inc. - Form 483, 2009-10-09
November, 2012 FDA 483 Contract Pharmaceutical Services of Australia Pty Ltd - Form 483, 2012-11-01
June, 2015 EIR Almac Pharma Services LLC - EIR, 2015-06-25
June, 2013 EIR PEL HEALTHCARE LLC - EIR, 2013-06-05
August, 2012 EIR WuXi Advanced Therapies Inc. - EIR, 2012-08-24
April, 2013 FDA 483 Pentec Health - Form 483, 2013-04-01
April, 2009 FDA 483 Cipla Ltd. - Form 483, 2009-04-09
August, 2009 FDA 483 KVK-TECH, INC - Form 483, 2009-08-31

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