FDA Investigator Ellen J Tave

Ellen J Tave has conducted inspections on 238 sites in 13 countries as of 06 May 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:

238

Last Inspection Date:

06 May 2024

Investigator Role:

FDA Investigator

Redica ID:

100004397

Countries of Inspections:

United States of America, Netherlands, Italy, United Kingdom of Great Britain and Northern Ireland, France, Canada, Korea (Republic of), Austria, Czechia, Germany, Switzerland, China, Ireland

FDA Investigators that have inspected at least one site in common with Ellen J Tave:

Abby Lmozeke Baker, Akbar J Zaidi, Akbar Javed, Albert F Peacock, PhD, Althea A Williams, Andrea A Branche, Andrew B Bevill, Anh M Lac, Ariel Cruz Figueroa, Brian J Ryan, Camerson E Moore, Camille D Brown, Carla J Lundi, Carol A Declouette Wilburn, Casey L Hamblin, CDR Sean T Creighton, Charles B Steinmiller, Charles D Brown, Cheryl D Mccall, Christine I Shaw, Christopher N Tran, Connie L Hannon Rabel, Constance M Dobbins, Cynthia A Harris, MD, RN, Daniel J Lahar, Daniel S Fam, Dannie E Rowland, Danny D Horner, Darla J Christopher, David H Smith, David M Beltran, Dennis R Butcher, Dolores Harper, Donna Ltartaglino Besone, Donzel R Lee, Dorothy W Lee, Dr. Jason R Caballero, Ed Gonzalez Vazquez, Edward D Mcdonald, Edward E Lockwood (EEL), Edward J Janik, Elizabeth D Connell, Elizabeth P Kinsella, Ellen J Kleintop, Enspect User, Eric M Padgett, Eric R Heebner, Erin La Rue, Frans E Mercado, Frederic W French, III, Fulton A Varner, Gatica, George G Calafactor, Gilbert Valdez, RS, Gloria A Milster, Grant L Davis, Gregson A Joseph, Hung V Le, Iris C Macinnes, J Elkins, Jacqueline S Warner, James A Beaulieu, James H Robinson, Jamie M Bumpas, Jamie P Webb, Janet B Abt, Janete F Guardia, Janice M Hickok, Jd Young, Jeffrey R Wooley, Jennifer A Downie, Jennifer O Dowdy, Jeremy R Read, Jesse A Vazquez, Jocelyn C Turner, Jodi M Gatica, Joel D Martinez, John A Sciacchitano, John D Mays, Johnson, Jose Martinez, Jr, Joseph M Edwin, Joshua J Silvestri, Kamara Tx, Karen A Coleman, Kari M Johansen, Kari M Laynor, Katlin N Stubbs, Kelly D Sheppard, Kevin T Nguyen, Kim M Downing, Kimberly Lewandowski Walker, Kirtida Patel, L Grant, Lance D Johnson, Lance Sindo, CIH, CQA, RS, Laureen M Geniusz, Lauren E Skokan, Lawton W Lum, LCDR Wilfred A Darang, Leighton Kn Gai, Lillie M Johnson, Lillie M Young, Linda Linh N Adams, Lisa R Whitt, Loretta Nemchik, Lori M Graham, Lorie S Hannappel, Luis E Gonzalez, Maira P Brading, Marc R Dickens, Marcia G Evans, Margaret M Annes, Maribeth G Grattan, Maribeth G Niesen, Mark C Flotte, Mark E Chan, Matthew A Humbard, Meredith L Sheridan, Merelynn Rhoten, Michael J Nerz, Monica J Wilkins, Monique Rac Lester, Msdap Gonzlezk, Olalere D Fasipe, Patrick B Cummings, Patrick D Stone, MS, Patty P Kaewussdangkul, Paula A Trost, Pauline N Logan, Perry H Gambrell, Philip M Steele, PhD, Phillip M Pontikos, Prabhu P Raju, Ralph Jerndal, Rebecca Co Bryan, Renisha M Garnes, Renisha M Shaw, Richard Jay Tucker, RS, Richard K Vogel, Robert E Spear, Ronald T Weber, Rose Ashley, Roy Baby, Samuel R Carter, Sarah A Hassas, Sarah Forney, Scott J Trsenjak, Scott R Nichols, PhD, Sha'tina R Alridge, Sonia R Peterson, Staci G Mcallister, Stacie A Woods, Stephen D Brown, Stephen D Eich, Stephen J Rabe, Steven L Strom, Steven R Ziser, Susan C Baltzer, Tania E Vizcaino, Terri E Gibson, Thai T Duong, Thomas E Friel, Timothy H Vo, Tracy J Washington, Tricia S Martinez, Uttaniti Limchumroon (Tom), Wendy R Blame, Yaw O Osei, Young M Yoon, Zerita White

Ellen J Tave's Documents

Publish Date	Document Type	Title
July, 2015	EIR	Batrik Medical Mfg., Inc. - EIR, 2015-07-16
September, 2012	FDA 483	Saad Usmani - Form 483, 2012-09-28
March, 2006	FDA 483	Ultrasonic Services, Inc. - Form 483, 2006-03-24
April, 2012	FDA 483	Instratek, Incorporated - Form 483, 2012-04-24
October, 2001	FDA 483 Response	Iso-Tex Diagnostics, Inc. - Form 483R, 2001-11-20
August, 2013	FDA 483	ArjoHuntleigh, Inc. - Form 483, 2013-08-02
April, 2011	FDA 483	Millar, Inc. - Form 483, 2011-04-21
August, 2019	FDA 483	Medical Informatics Corp. - Form 483, 2019-08-02
September, 2017	EIR	Osteomed, LLC - EIR, 2017-09-22
November, 2011	FDA 483	Ototronix, LLC - Form 483, 2011-11-10
December, 2019	FDA 483	Trilliant Surgical, LLC - Form 483, 2019-12-11
September, 2019	FDA 483	Molecular Biologicals, LLC - Form 483, 2019-09-26
May, 2022	FDA 483	Nu Dimension Tech Ventures, Llc - Form 483, 2022-05-04
February, 2020	FDA 483	Ansh Labs, LLC - Form 483, 2020-02-10
April, 2016	FDA 483	Cavex Holland B.V. - Form 483, 2016-04-01
October, 2019	FDA 483	Amperor Inc. - Form 483, 2019-10-29
April, 2002	EIR	Ramco Laboratories, Inc - EIR, 2002-04-29
September, 2004	FDA 483 Response	LivaNova USA, Inc. - Form 483R, 2004-10-07
July, 2015	FDA 483	Northern Digital Inc. - Form 483, 2015-07-09
January, 2002	EIR	LivaNova USA, Inc. - EIR, 2002-01-22
October, 2022	FDA 483	ITI Manufacturing, Inc. - Form 483, 2022-10-28
June, 2002	FDA 483	Immunovision, Inc - Form 483, 2002-06-07
February, 2003	EIR	UO Equipment Company - EIR, 2003-02-19
March, 2022	FDA 483	Texas Medical Technology Inc. - Form 483, 2022-03-03
May, 2021	FDA 483	LivaNova USA, Inc. - Form 483, 2021-05-04
October, 2009	FDA 483	Mueller Water Conditioning, Inc - Form 483, 2009-10-29
July, 2009	FDA 483	Smith & Nephew, Inc. Advanced Surgical Devices Division - Form 483, 2009-07-31
August, 2023	FDA 483	SMITHWORKS, INC. - Form 483, 2023-08-29
September, 2018	FDA 483	Carefusion Corporation - Form 483, 2018-09-28
February, 2010	FDA 483	Sharps Compliance, Inc. - Form 483, 2010-02-10
November, 2021	FDA 483	ErgoMed, Inc. - Form 483, 2021-11-05
September, 2017	FDA 483	Osteomed, LLC - Form 483, 2017-09-22
February, 2011	FDA 483	Lone Star Medical Products, Inc. - Form 483, 2011-02-24
October, 2016	EIR	Abbott Point of Care Canada Limited - EIR, 2016-10-20
September, 2022	FDA 483	Sea-Long Medical Systems, LLC - Form 483, 2022-09-08
June, 2004	FDA 483	WNCK, Inc - Form 483, 2004-06-18
June, 2010	FDA 483	Zeno Corporation - Form 483, 2010-06-21
April, 2002	FDA 483	Ramco Laboratories, Inc - Form 483, 2002-04-29
November, 2003	EIR	Lordex, Inc - EIR, 2003-11-05
February, 2005	FDA 483	MJM International Corporation - Form 483, 2005-02-11
June, 2016	FDA 483 Response	Trilliant Surgical, LLC - Form 483R, 2016-07-19
November, 2018	FDA 483	Sharps Compliance, Inc. - Form 483, 2018-11-15
February, 2003	FDA 483	UO Equipment Company - Form 483, 2003-02-19
December, 2012	FDA 483	Garaventa (Canada), Ltd. - Form 483, 2012-12-06
September, 2021	FDA 483	CardioQuip, LLC - Form 483, 2021-09-17
April, 2018	FDA 483	Nusmile, Ltd. - Form 483, 2018-04-16
June, 2011	FDA 483	Gresco Products, Inc. - Form 483, 2011-06-20
August, 2012	FDA 483	Lone Star Medical Products, Inc. - Form 483, 2012-08-06
August, 2001	FDA 483	Ramco Laboratories, Inc - Form 483, 2001-08-28
October, 2014	FDA 483	RMD, LLC - Form 483, 2014-10-17
June, 2002	EIR	Immunovision, Inc - EIR, 2002-06-07
March, 2002	EIR	Encompass Group, LLC - EIR, 2002-03-22
February, 2001	FDA 483	LivaNova USA, Inc. - Form 483, 2001-02-01
March, 2002	FDA 483	Encompass Group, LLC - Form 483, 2002-03-22
February, 2015	FDA 483	Trilliant Surgical, LLC - Form 483, 2015-02-12
September, 2016	FDA 483	Surgik LC - Form 483, 2016-09-16
February, 2001	EIR	LivaNova USA, Inc. - EIR, 2001-02-01
June, 2006	FDA 483	Care Products, Inc - Form 483, 2006-06-16
September, 2018	FDA 483	EMIT Corporation - Form 483, 2018-09-06
September, 2004	FDA 483	LivaNova USA, Inc. - Form 483, 2004-09-15
November, 2003	FDA 483	Lordex, Inc - Form 483, 2003-11-05
March, 2014	FDA 483	Instratek, Incorporated - Form 483, 2014-03-24
August, 2000	EIR	Merit Medical Systems, Inc - EIR, 2000-08-25
January, 2002	FDA 483	LivaNova USA, Inc. - Form 483, 2002-01-22
May, 2013	FDA 483	IDEV Technologies, Inc. - Form 483, 2013-05-03
April, 2015	FDA 483	Shreyaskumar R. Patel, MD - Form 483, 2015-04-02
March, 2013	FDA 483	Helena Laboratories, Inc - Form 483, 2013-03-01
January, 2011	FDA 483	Hsmg, Inc. D/b/a Smartinfuser Usa - Form 483, 2011-01-25
March, 2013	FDA 483	Helena Laboratories, Corp. - Form 483, 2013-03-01
August, 2019	FDA 483	Texas Eye Prosthetics, LLC - Form 483, 2019-08-12
June, 2009	FDA 483	Osteogenics Biomedical, Inc. - Form 483, 2009-06-12
December, 2012	FDA 483	A. R. Medicom Inc. - Form 483, 2012-12-13
March, 2015	FDA 483	Wexler Surgical, Inc. - Form 483, 2015-03-20
January, 2022	FDA 483	Nelson Environmental Technologies, Inc. - Form 483, 2022-01-24
April, 2023	FDA 483	Forcemech International LLC - Form 483, 2023-04-06
January, 2023	FDA 483	Sharps Compliance, Inc. - Form 483, 2023-01-31
November, 2005	FDA 483 Response	WNCK, Inc - Form 483R, 2005-11-10
March, 2015	EIR	Wexler Surgical, Inc. - EIR, 2015-03-20
December, 2018	FDA 483	Helena Laboratories, Corp. - Form 483, 2018-12-14
March, 2023	FDA 483	EMIT Corporation - Form 483, 2023-03-07
September, 2022	FDA 483	Suez Treatment Solutions, Inc. - Form 483, 2022-09-16
August, 2011	FDA 483	Zeno Corporation - Form 483, 2011-08-01
January, 2002	FDA 483 Response	LivaNova USA, Inc. - Form 483R, 2002-02-20
March, 2020	FDA 483	S&S X-Ray Products, Inc. - Form 483, 2020-03-09
June, 2004	EIR	WNCK, Inc - EIR, 2004-06-18
December, 2022	FDA 483	Louisville APL Diagnostics, Inc. - Form 483, 2022-12-19
October, 2001	FDA 483	Iso-Tex Diagnostics, Inc. - Form 483, 2001-10-04
January, 2000	EIR	LivaNova USA, Inc. - EIR, 2000-01-27
December, 2007	FDA 483	Mentor Texas, LP. - Form 483, 2007-12-07
July, 2023	FDA 483	Nelson Environmental Technologies, Inc. - Form 483, 2023-07-27
August, 2010	FDA 483	Quest Medical, Inc. - Form 483, 2010-08-27
August, 2014	FDA 483	International Science & Technology, LP, DBA Diamatrix Ltd. - Form 483, 2014-08-01
March, 2001	FDA 483	Transplantation Research Foundation - Form 483, 2001-03-19
January, 2016	EIR	Alcon Research, LTD. - EIR, 2016-01-21
September, 2004	EIR	LivaNova USA, Inc. - EIR, 2004-09-15
June, 2016	FDA 483	Trilliant Surgical, LLC - Form 483, 2016-06-27
April, 2022	FDA 483	Forcemech International LLC - Form 483, 2022-04-04
July, 2024	FDA 483	Advanced Ambulatory, Inc. - Form 483, 2024-07-31
May, 2024	FDA 483	QBTech Inc. - Form 483, 2024-05-23
March, 2024	FDA 483	Texas Injection Molding, LLC - Form 483, 2024-03-21

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.

Talk to sales to access our investigator profiles

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