FDA Investigator Tara R Gooen

Tara R Gooen has inspections in 2 countries as of 01 Aug 2023. Tara R Gooen has collaborated with a combinined 3250 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
28
Last Inspection Date:
01 Aug 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
100004165
Country:
United States of America, Netherlands
Co-Investigator(s):
Addam S Reynolds, Adetutu M Gidado, Alberto A Viciedo, Alicia M Mozzachio, Allen Lou, Amanda L Baskin, Amatul H Marium, Amy Devlin, PhD, Amy L Singer, Amy M Codella, Amy M Cramer, Anders W Evenson, Ankur C Patel, Annemarie B Randow, Annemarie Bodnar, Anthony A Charity, Anthony J Donato, Anthony N Onianwa, Ashutosh Rao, PhD, Atul J Agrawal, Barbara J Maulfair, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Bonita S Chester, Brian D Nicholson, Brittani N Franklin, Byungja E Marciante, Carrie Ann Plucinski, Charles J Chacko, Christina A Miller, Christina N Maurino, Christopher D Leach, Craig W Swanson, Daniel B Arrecis, Daniel J Grabicki, Dariusz Galezowski, David A Paterson, Dawn L Wydner, Deborah B Nixon, Dennis Cantellops Paite, Dennis E Guilfoyle, PhD, Diane M Gubernot, Donald C Obenhuber, PhD, Donald L Lech, Donna A Katz, Dorothy J Denes, Douglas A Campbell, Douglas C Kovacs, Dr. Sriram Subramaniam, PhD, Elena Karnaukhova, PhD, Emest F Bizjak, Emmanuel J Ramos, Eric Rothschild, Erin D Mccaffery, Ferderick Razzaghi, Frank J Marciniak, Frank W Perrella, Frank Wackes, Frederick Razzaghi, Guerlain Ulysse, Helen B Ricalde, Helen Verdel, James D Planchon, Jason F Chancey, Jean M Kelahan, Jeffrey A Sommers, Jeffrey J Ebersole, Jennifer C Adams, Jennifer C Johnson, Jennifer Macmillan, Jonathan G Swoboda, Jonee J Mearns, Jorge L Guadalupe, Jose Acruz Gonzalez, Jose M Cayuela, Joseph F Mcginnis, RPh, Joy R Kelna, Joy Rkozlowski Klena, Julie D Bringger, Justine Tomasso, Karen D'crazio, Karen E D'orazio, Karishma G Gopaul, Karishma Gopaul, Keith M Reilley, Keith M Reilly, Kelli F Dobilas, Kevin Obrien, Kham Phommachanh, Kimberley A Hoefen, Kinh Q Mac, Kristy A Zielny, Larry K Austin, Lata C Mathew, PhD, Latoya A Griffith, Lauren L Vajo, LCDR Mark A Jimenez, RN, Leigh Anne Myers, Li Li, Liatte Kreuger, PharmD, Lisa Harlan, Marcellinus D Dordunoo, Marea K Harmon, Margaret M Sands, Margaret Sand, Maria Estrella, Marisa E Stock, Marisol Faberlle, Martin R Vowell, Marvin D Jones, Matthew A Spataro, Matthew Sparato, Melba Trivera Clavell, Melissa A Freeman, Melissa T Roy, Meredith L Sheridan, Merril E Racke, Meyer J Slobotsky, Michael R Klapal, Michael Serrano, Michele Gottshall, Michele L Glendenning, Milva E Melendez, Milva Emelendez Perales, Monika Borkowska, Morea K Harmen, Nancy L Rolli, Neal D Singletary, PhD, Nerizza B Guerin, Nicholas A Violand, Nicholas F Lyons, Nicole K Trudel, Niketa Patel, Nikki S Ramirez, Omotunde O Osunsanmi, Patrick L Wisor, Patsy J Domingo, Paul L Bellamy, Paula A Trost, Peng Zhou, Peter R Lenahan, Ralph A Erickson, Remache, Reyes Candau Chacon, PhD, Richard H Penta, Richard Heath Coats, Robert G Ruff, Robert J Maffei, Robert Sharpnack, Rochelle L Campbell, Rochelle L Cross, Russell J Glapion, Russell K Riley, Sarah Adella Fave, Sarah Forney, Sean G Casey, Shana L Williams, Sinai Davis, Stephen J Mottola, Steven C Madzo, Steven M Weinman, Susan M Halsted, Susan P Bruederle, Susan W Ciani, Tania E Garcia, Tania E Vizcaino, Tara G Bizjak, Tara R Bizjak, Temar Q Williams, Terri L Dodds, Tonia F Bernard, Tracey L Harris, Valerie C Reed, Valerie Reed, Victoria Spivak, Wayne E Seifert, Wayne T Smith, Wendy G Tan, PhD, Yvesna C Blaise, Yvins Dezan, Yvonne E Lozano, Zakaria I Ganiyu

Tara R Gooen's Documents

Publish Date Document Type Title
October, 2003 FDA 483 Packaging Systems, LLC - Form 483, 2003-10-15
April, 2006 FDA 483 Leading Pharma, LLC - Form 483, 2006-04-18
November, 2003 EIR Ivax Pharmaceuticals Inc - EIR, 2003-11-17
August, 2008 EIR Woodstock Sterile Solutions, Inc - EIR, 2008-08-27
July, 2003 EIR Vantage Specialty Ingredients, Inc - EIR, 2003-07-30
October, 2006 FDA 483 Ameriderm Laboratories, Ltd. - Form 483, 2006-10-31
April, 2003 FDA 483 Penick Corp - Form 483, 2003-04-03
August, 2003 FDA 483 Response ACUPAC PACKAGING INC - Form 483R, 2003-09-03
June, 2003 EIR Unigene Laboratories, Inc. - EIR, 2003-06-16
June, 2006 FDA 483 N.V. Organon - Form 483, 2006-06-28
November, 2003 FDA 483 Ivax Pharmaceuticals Inc - Form 483, 2003-11-19
November, 2005 EIR Amneal Pharmaceuticals, LLC - EIR, 2005-11-25
July, 2003 FDA 483 Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics - Form 483, 2003-07-10
December, 2003 FDA 483 Response Consumer Product Testing Company, Inc - Form 483R, 2004-01-09
April, 2003 EIR Compass Pharma Services, LLC - EIR, 2003-04-10
March, 2003 EIR Able Laboratories Inc. - EIR, 2003-03-14
August, 2003 EIR ACUPAC PACKAGING INC - EIR, 2003-08-11
February, 2006 EIR Actavis Totowa LLC - EIR, 2006-02-08
August, 2003 FDA 483 ACUPAC PACKAGING INC - Form 483, 2003-08-11
June, 2005 EIR Amneal Pharmaceuticals, LLC - EIR, 2005-06-07
October, 2003 EIR Packaging Systems, LLC - EIR, 2003-10-15
December, 2003 EIR Consumer Product Testing Company, Inc - EIR, 2003-12-18
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-28
April, 2003 EIR Johnson & Johnson Healthcare Products Div. Mcneil-ppc, Inc. - EIR, 2003-04-24
October, 2004 EIR Mayne Pharma (USA) Inc. - EIR, 2004-10-06
October, 2004 FDA 483 Mayne Pharma (USA) Inc. - Form 483, 2004-10-06
August, 2005 EIR SGS North America Inc. - EIR, 2005-08-19
December, 2005 FDA 483 Merck, Inc. - Form 483, 2005-12-14
September, 2002 FDA 483 Bergen Comm Reg Blood Center - Form 483, 2002-09-20
April, 2003 EIR Penick Corp - EIR, 2003-04-03
May, 2006 EIR Aphena Pharma Solutions - New Jersey, LLC - EIR, 2006-05-11
August, 2007 FDA 483 Pfizer Inc - Form 483, 2007-08-15
June, 2003 FDA 483 Response Unigene Laboratories, Inc. - Form 483R, 2003-06-27
June, 2005 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2005-06-07
August, 2005 FDA 483 SGS North America Inc. - Form 483, 2005-08-19
October, 2003 FDA 483 Response Packaging Systems, LLC - Form 483R, 2003-11-24
July, 2003 EIR Hudson Cosmetics Manufacturing Corp. DBA Paramount Cosmetics - EIR, 2003-07-10
December, 2003 FDA 483 Consumer Product Testing Company, Inc - Form 483, 2003-12-18
March, 2006 FDA 483 Complete Analysis Laboratories Inc - Form 483, 2006-03-16
April, 2003 FDA 483 Johnson & Johnson Healthcare Products Div. Mcneil-ppc, Inc. - Form 483, 2003-04-24
August, 2005 FDA 483 Response SGS North America Inc. - Form 483R, 2005-09-14
November, 2005 FDA 483 Response Amneal Pharmaceuticals, LLC - Form 483R, 2005-12-19
August, 2008 FDA 483 Woodstock Sterile Solutions, Inc - Form 483, 2008-08-27
September, 2004 EIR Barr Laboratories Inc - EIR, 2004-09-02
April, 2010 FDA 483 Renaissance Lakewood LLC - Form 483, 2010-04-01
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
June, 2003 FDA 483 Unigene Laboratories, Inc. - Form 483, 2003-06-16
May, 2006 FDA 483 Aphena Pharma Solutions - New Jersey, LLC - Form 483, 2006-05-11
March, 2003 FDA 483 Able Laboratories Inc. - Form 483, 2003-03-14
July, 2003 EIR GENERICHEM CORPORATION - EIR, 2003-07-22
November, 2005 FDA 483 Amneal Pharmaceuticals, LLC - Form 483, 2005-12-12
June, 2005 FDA 483 Response Amneal Pharmaceuticals, LLC - Form 483R, 2005-06-16
April, 2003 FDA 483 Response Penick Corp - Form 483R, 2003-04-10
June, 2006 EIR N.V. Organon - EIR, 2006-06-28

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