FDA Investigator Tara G Bizjak

Tara G Bizjak has conducted inspections on 74 sites in 5 countries as of 26 Sep 2011. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
74
Last Inspection Date:
26 Sep 2011
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, Netherlands, India, United Kingdom of Great Britain and Northern Ireland, Malta
FDA Investigators that have inspected at least one site in common with Tara G Bizjak:
Abdollah Koolivand, Addam S Reynolds, Ademola O Daramola, Adetutu M Gidado, Albert M Brindle, Alberto A Viciedo, Allen Lou, Amatul H Marium, Amy L Singer, Amy M Codella, Amy M Cramer, Amy Wyan Mai, Ana S Cabrera, Andrew O Ejiofor, Ankur C Patel, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Anthony A Charity, Anthony J Donato, Anthony M Criscuolo, Jr, Anthony N Onianwa, Arsen Karapetyan, Ashutosh Rao, PhD, Atul J Agrawal, Barbara J Maulfair, Barbara Janine Breithaupt, Barbara Jwilimczyk Macri, Bonita S Chester, Burnell M Henry, Byungja E Marciante, Cary Greene, Charles J Chacko, Christina N Maurino, Christopher S Keating, Craig D Zagata, Craig W Swanson, Cynthia Jim, CSO, Daniel J Grabicki, Daniel J Roberts, Dawn C Olenjack, Dawn L Wydner, Deborah B Nixon, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Dhaval H Patel, Diane M Gubernot, Dipesh K Shah, Donald C Obenhuber, PhD, Donald L Lech, Dorothy J Denes, Douglas A Campbell, Douglas C Kovacs, Dr. Sriram Subramaniam, PhD, Elena Karnaukhova, PhD, Emest F Bizjak, Emmanuel Jramos Maldonado, Eric Rothschild, Erin D Mccaffery, Farhana Khan, Frank J Marciniak, Frank W Perrella, Frederick F Razzaghi, George M Ibrahim, Gianine E Delade, Gianine E Tompkins, Guerlain Ulysse, Guo Q Shen, Helen B Ricalde, Helen Verdel, Ivis L Negron, James C Maclaughlin, James D Planchon, Javier E Santos, Jawaid Hamid, Jay B Shah, Jean M Kelahan, Jeffery B Medwid, PhD, Jeffrey J Ebersole, Jennifer Macmillan, Jessica S Estriplet, Jogy George, Jonee J Mearns, Jorge L Guadalupe, Jose A Lopez, Jose Acruz Gonzalez, Jose M Cayuela, Joseph F Mcginnis, RPh, Joy Rkozlowski Klena, Julie D Bringger, Junho Pak, Justine Tomasso, Karen E D'orazio, Karishma G Gopaul, Keith M Reilly, Kelli F Dobilas, Kelli F Regenye, Kelly Doremus, Kelly I Anderson, Kevin Obrien, Kham Phommachanh, Kimberley A Hoefen, Kinh Q Mac, Kristy A Zielny, Krystal O Ogunremi, Laishan L Lam, Lakecha N Lewis, Lata C Mathew, PhD, Lauren L Vajo, Laurie B Frazier, Lawrence R Johnson, Li Li, Liatte Kreuger, PharmD, Libia M Lugo, Lisa B Hall, Lisa Harlan, Lisa L Flores, Luis Mburgos Medero, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Maria Estrella, Maridalia Torres Irizarry, Marisol Faberlle, Marjorie D Schultz, Marvin D Jones, Massoud Motamed, Matthew A Spataro, Melba Trivera Clavell, Melissa A Freeman, Melissa B Libby, Melissa J Garcia, Melissa T Roy, Meredith L Sheridan, Merril E Racke, Meyer J Slobotsky, Michael O Idowu, Michael R Klapal, Michael Serrano, Michele Gottshall, Michele L Obert, Monika Borkowska, Nancy F Scheraga, Nancy L Rolli, Nancy M Espinal, Nerizza B Guerin, Nicholas A Violand, Nicholas L Paulin, Nicole K Trudel, Niketa Patel, Nikki S Ramirez, Omotunde O Osunsanmi, Parul M Patel, Patrick L Wisor, Paul L Bellamy, Peter R Lenahan, Pratik S Upadhyay, DDC, Rafeeq A Habeeb, Raihan A Chowdhury, Ramon A Hernandez, Rebecca E Dombrowski, Rebecca Parrilla, Regina T Brown, Remache, Reyes Candau Chacon, PhD, Richard D Manney, Richard H Penta, Richard Heath Coats, Robert G Ruff, Robert J Maffei, Robert Sharpnack, Robin P Mathew, Rochelle K Kimmel, Rochelle L Campbell, Rochelle L Cross, Roger J Adams, Russell J Glapion, Saleem A Akhtar, Sandra A Boyd, Sandra A Hughes, Sarah Adella Fave, Sarah Forney, Satheesh Thomas, Schultz, Sean G Casey, Sherri J Liu, Shirshendu K Deb, PhD, Sinai I Davis, Stephanie T Durso, Stephen J Mottola, Stephenie M Ortiz, Steven C Madzo, Steven M Weinman, Susan M Halsted, Susanna E Ford, Tania E Garcia, Tania E Vizcaino, Tara R Gooen, Temar Q Williams, Terri L Dodds, Tiffani D Wilson, Tomika L Bivens, Tonia F Bernard, Tracey L Harris, Tressa T Lewis, Tricia S Martinez, Unnee Ranjan, Valerie C Reed, Valerie Reed, Victoria Spivak, Wayne J Meyer, Wayne T Smith, William J Leonard, Xikui Chen (nmi), PhD, Yoriann M Cabrera Bartolomei, Youmin Wang, Yvesna C Blaise, Yvins Dezan, Zakaria I Ganiyu

Tara G Bizjak's Documents

Publish Date Document Type Title
June, 2003 FDA 483 Response Unigene Laboratories, Inc. - Form 483R, 2003-06-27
April, 2003 FDA 483 Response Penick Corp - Form 483R, 2003-04-10
December, 2005 FDA 483 Merck, Inc. - Form 483, 2005-12-14
June, 2003 FDA 483 Unigene Laboratories, Inc. - Form 483, 2003-06-16
April, 2003 EIR Penick Corp - EIR, 2003-04-03
June, 2005 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2005-06-07
June, 2005 FDA 483 Response Amneal Pharmaceuticals, LLC - Form 483R, 2005-06-16
March, 2003 FDA 483 Able Laboratories Inc. - Form 483, 2003-03-14
November, 2005 EIR Amneal Pharmaceuticals, LLC - EIR, 2005-11-25
June, 2006 FDA 483 N.V. Organon - Form 483, 2006-06-28
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-01
May, 2006 EIR Aphena Pharma Solutions - New Jersey, LLC - EIR, 2006-05-11
July, 2003 FDA 483 Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics - Form 483, 2003-07-10
October, 2004 FDA 483 Mayne Pharma (USA) Inc. - Form 483, 2004-10-06
October, 2003 EIR Packaging Systems, LLC - EIR, 2003-10-15
April, 2003 EIR Johnson & Johnson Healthcare Products Div. Mcneil-ppc, Inc. - EIR, 2003-04-24
December, 2003 EIR Consumer Product Testing Company - EIR, 2003-12-18
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-28
October, 2004 EIR Mayne Pharma (USA) Inc. - EIR, 2004-10-06
December, 2003 FDA 483 Response Consumer Product Testing Company - Form 483R, 2004-01-09
October, 2006 FDA 483 Ameriderm Laboratories, Ltd. - Form 483, 2006-10-31
August, 2005 FDA 483 SGS North America Inc. - Form 483, 2005-08-19
September, 2002 FDA 483 Bergen Comm Reg Blood Center - Form 483, 2002-09-20
July, 2003 EIR Vantage Specialty Ingredients, Inc - EIR, 2003-07-30
October, 2003 FDA 483 Response Packaging Systems, LLC - Form 483R, 2003-11-24
September, 2004 EIR Barr Laboratories Inc - EIR, 2004-09-02
November, 2003 EIR Ivax Pharmaceuticals Inc - EIR, 2003-11-17
December, 2003 FDA 483 Consumer Product Testing Company - Form 483, 2003-12-18
March, 2006 FDA 483 Complete Analysis Laboratories Inc - Form 483, 2006-03-16
April, 2003 EIR Compass Pharma Services, LLC - EIR, 2003-04-10
April, 2003 FDA 483 Penick Corp - Form 483, 2003-04-03
November, 2005 FDA 483 Response Amneal Pharmaceuticals, LLC - Form 483R, 2005-12-19
August, 2005 EIR SGS North America Inc. - EIR, 2005-08-19
April, 2006 FDA 483 LEADING PHARMA, LLC - Form 483, 2006-04-18
November, 2003 FDA 483 Ivax Pharmaceuticals Inc - Form 483, 2003-11-19
October, 2003 FDA 483 Packaging Systems, LLC - Form 483, 2003-10-15
October, 2002 FDA 483 B.E.C. Manufacturing Corp. - Form 483, 2002-10-31
February, 2006 FDA 483 Actavis Totowa LLC - Form 483, 2006-02-08
March, 2003 FDA 483 Response Able Laboratories Inc. - Form 483R, 2003-03-19
May, 2006 FDA 483 Aphena Pharma Solutions - New Jersey, LLC - Form 483, 2006-05-11
June, 2006 EIR N.V. Organon - EIR, 2006-06-28
March, 2003 EIR Able Laboratories Inc. - EIR, 2003-03-14
August, 2003 EIR ACUPAC PACKAGING INC - EIR, 2003-08-11
August, 2003 FDA 483 Response ACUPAC PACKAGING INC - Form 483R, 2003-09-03
November, 2005 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2005-12-12
February, 2006 EIR Actavis Totowa LLC - EIR, 2006-02-08
August, 2005 FDA 483 Response SGS North America Inc. - Form 483R, 2005-09-14
July, 2003 EIR GENERICHEM CORPORATION - EIR, 2003-07-22
July, 2003 EIR Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics - EIR, 2003-07-10
June, 2005 EIR Amneal Pharmaceuticals, LLC - EIR, 2005-06-07
June, 2003 EIR Unigene Laboratories, Inc. - EIR, 2003-06-16
August, 2003 FDA 483 ACUPAC PACKAGING INC - Form 483, 2003-08-11
April, 2003 FDA 483 Johnson & Johnson Healthcare Products Div. Mcneil-ppc, Inc. - Form 483, 2003-04-24

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