FDA Investigator Loretta Nemchik

Loretta Nemchik has inspections in 10 countries as of 03 Nov 2023. Loretta Nemchik has collaborated with a combinined 4131 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:

239

Last Inspection Date:

03 Nov 2023

Investigator Role:

FDA Investigator

Redica ID:

100007092

Country:

United States of America, Norway, United Kingdom of Great Britain and Northern Ireland, Italy, Canada, Germany, Sweden, Ireland, Switzerland

Co-Investigator(s):

A Williams, Addam S Reynolds, Adetutu M Gidado, Alan C Gion, Alberto A Viciedo, Allen Lou, Amanda Jones, Amy Franklin, Amy L Singer, Amy Lynn Frankshun, PhD, Amy M Cramer, Anastasia I Offordile, Anita R Michael, Ankur C Patel, Ann Marie Montemurro, Annemarie B Randow, Annemarie Bodnar, Anthony M Criscuolo, Jr, Ashley A Mutawakkil, Atul J Agrawal, Barbara J Wilimczyk, Barbara Jwilimczyk Macri, Benjamin W Anderson, Bill Tacket, Jr, Bing Lin, Brandon L Mariner, Brenda S Zimmer, PhD, Burnell M Henry, Byungja E Marciante, Byunja E Marciante, Carol A Perry, Carol A Robles, Cary Greene, Cassandra L Abellard, Charles L Larson, Charles M Edwards, Cherie T Parker, Christopher J Hurst, Cynthia A Harris, MD, RN, Daniel J Grabicki, Daniel J Lahar, David A Oluwo, David H Smith, Dawn L Wydner, Dawn M Braswell, Deborah J Parris, Denise M Visco, Investigator, Denise M Visu, Dennis E Guilfoyle, PhD, Devon Jenkins, Dhaval H Patel, Diane B Radice, Donna Ltartaglino Besone, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Abhijit Raha, PhD, Dr. Guang Gao, PhD, E Marciante, Edward D Mcdonald, Elizabeth B Griffin, Ellen J Tave, Emest F Bizjak, Emily A Walters, Eric J Cunningham, Eric Rothschild, Erin D Mccaffery, Esteban Beltran, Frank J Marci, Frank J Marciniak, Frederick Razzaghi, George Pyramides, Gobiga Vanniyasingam, Guerlain Ulysse, Harperd, Helen B Ricalde, Herrmann, Himanshu Gupta, PhD, Jacqueline Mdiaz Albertini, James M Odonnell, James R Birkenstamm, James W Leonette, James W Plucinski, Janet A Rajan, Janete F Guardia, Jason M Sluzynski, Jay B Shah, Jean Blackston Hill, Jean M Kelahan, Jennifer A Bazergui, Jennifer Macmillan, Jill M Sooter, Jo Annc Declement, Jocelyn M Muggli, Jogy George, John D White, Jonathan G Matrisciano, Jonathan S Helfgott, Jonee J Mearns, Jose M Cayuela, Jose O Hernandez, Joseph L Despins, PhD, Jot R Klena, Joy Rkozlowski Klena, Juanita P Versace, Judith A Jones, Justine Tomasso, Karen E D'orazio, Karen F Tomaziefski, Karen M Ferguson, Keith A Schwartz, Kelli F Dobilas, King, Kinh Q Mac, Kish Bolden, Kris K Moore, Kristy A Zielny, Krystyna M Kitson, Kwong P Lee, Laishan L Lam, Lauren L Vajo, Lawrence Harmon, Jr, LCDR Wilfred A Darang, Li Li, Lisa Harlan, Lisa Mathew, Loretta Nemchick, Loretta Wemchik, Manhar R Patel, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marcia Gelber, Marea K Harmon, Margaret M Sands, Maria Estrella, Maribeth G Niesen, Mark E Parmon, Martha T Olone, Matthew S Mccollough, Mayar M Mussa, Melissa A Zuppe, Melissa I Michurski, Melissa T Roy, Melkamu Getie Kebtie, PhD, Meredith L Sheridan, Meyer J Slobotsky, Michael F Skelly, PhD, Michael J Nerz, Michael R Klapal, Michael Rosner, Michael Serrano, Michael Skelly, Michelle J Glembin, Michelle L Johnson, Miguel G Manzano, Monica L Gutierrez, Mpris Inspector, Nadia R Barreda, Nancy F Scheraga, Nancy M Espinal, Nebil A Oumer, Nerizza B Guerin, Nicholas A Violand, Nicole S Williams, Nikisha M Bolden, Nina Yang, Norman Wong, Omotunde O Osunsanmi, Patrick C Klotzbuecher, Paul E Stein, Paul L Bellamy, Paul Mouris, Paula A Trost, Paula J Bretz, Peter R Lenahan, Phillip M Pontikos, Prabhu P Raju, Preston M Lee, Raymond L Cheung, Regina T Brown, Remache, Richard D Manney, Robert G Ruff, Robert Sharpnack, Robert W Mccullough, Rochelle L Cross, Ronald Ifraimov, Rosanna M Goodrich, Rosario D'costa, Rose Ljean Mary, Rose M Ashley, Russell J Glapion, Samir C Gala, Sandra Kershaw, Sands, Sara M Onyango, Sarah A Hassas, Sarah Forney, Sargum C Sood, Satheesh K Podaralla, Schultz, Seng Ching Hwang, Shaquenta Y Perkins, Sherri J Liu, Shirley H Isbill, Shirley Isbill, Shirley S Wen, Simone E Pitts, Sinai Davis, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephanie T Durso, Stephen J Mottola, Steven B Barber, Susan M Jackson, Syeda N Mahazabin, Tamil Arasu, PhD, Tania E Vizcaino, Teigan M Mule, Tiki J Dixon, Todd J Maushart, Tyanna N Hadley, Valerie C Reed, Victoria Spivak, Vivin George, Wayne J Meyer, William R Chang, William W Dotts, Xi Kui, cdzn, Xikui Chen (nmi), PhD, Xingfang Li, MD, Yehualashet A Gessesse, Yiyue Zhang (nmi), PhD, Yvesna C Blaise, Yvins Dezan

Loretta Nemchik's Documents

Publish Date	Document Type	Title
July, 2002	EIR	Cooper Health System IRB - EIR, 2002-07-01
January, 2002	FDA 483	St Jude Medical Inc - Form 483, 2002-01-25
June, 2014	FDA 483	EPR Industries, LLC - Form 483, 2014-06-06
August, 2015	EIR	Tris Pharma Inc - EIR, 2015-08-12
July, 2014	FDA 483	David R. Hassman, DO - Form 483, 2014-07-18
May, 2005	FDA 483	Labcorp Early Development Laboratories, Inc. - Form 483, 2005-05-06
September, 2001	FDA 483 Response	Electric Mobility Corp - Form 483R, 2001-09-21
August, 2008	FDA 483	Hassman, David, DO - Form 483, 2008-08-14
September, 2001	FDA 483	Electric Mobility Corp - Form 483, 2001-09-20
February, 2001	EIR	Pliva, Inc. - EIR, 2001-02-05
December, 2000	FDA 483	J Lloyd Medical Inc - Form 483, 2000-12-20
November, 2002	EIR	EMD Millipore Corporation - EIR, 2002-11-26
November, 2010	FDA 483	Electric Mobility Corp - Form 483, 2010-11-16
April, 2014	EIR	MTI Precision Products LLC. - EIR, 2014-04-30
May, 2012	FDA 483	Compression Therapy Concepts, Inc. - Form 483, 2012-05-31
May, 2001	FDA 483	St Jude Medical Inc - Form 483, 2001-05-07
April, 2011	FDA 483	Origio Inc. - Form 483, 2011-04-07
April, 2005	EIR	Arrow International, Inc. - EIR, 2005-04-11
May, 2002	FDA 483	Fresenius Medical Care - Form 483, 2002-05-03
September, 2015	FDA 483	Medplast West Berlin, Inc - Form 483, 2015-09-28
November, 2011	FDA 483	Electric Mobility Corp - Form 483, 2011-11-16
December, 2003	FDA 483	Dvorin, Donald Dr. - Form 483, 2003-12-23
April, 2005	FDA 483 Response	Arrow International, Inc. - Form 483R, 2005-06-03
March, 2009	FDA 483	UltraRad Corporation - Form 483, 2009-03-05
September, 2001	EIR	Electric Mobility Corp - EIR, 2001-09-20
December, 2000	FDA 483 Response	J Lloyd Medical Inc - Form 483R, 2001-01-10
January, 2009	EIR	Steven J. Glass, M.D. - EIR, 2009-01-26
July, 2012	FDA 483	Integra LifeSciences Corporation - Form 483, 2012-07-30
August, 2011	FDA 483	Integra LifeSciences Corporation - Form 483, 2011-08-25
February, 2002	FDA 483 Response	Electric Mobility Corp - Form 483R, 2002-02-12
May, 2016	FDA 483	Lake Region Medical, Ltd. - Form 483, 2016-05-06
April, 2012	FDA 483	Akers Biosciences, Inc. - Form 483, 2012-04-11
February, 2001	EIR	Origio Inc. - EIR, 2001-02-26
February, 2003	FDA 483	Electric Mobility Corp - Form 483, 2003-02-11
April, 2007	EIR	Lucasti Christopher, D.O. - EIR, 2007-04-25
February, 2001	FDA 483 Response	Pliva, Inc. - Form 483R, 2001-02-16
December, 2010	FDA 483	American Bio Medica Corporation - Form 483, 2010-12-23
February, 2012	FDA 483	Pharmaceutical Innovations, Inc. - Form 483, 2012-02-27
August, 2001	EIR	Sterigenics US LLC - EIR, 2001-08-28
November, 2002	FDA 483	EMD Millipore Corporation - Form 483, 2002-11-26
February, 2006	EIR	Ohm Laboratories Inc. - EIR, 2006-02-10
July, 2001	FDA 483	Berlin Medical Associates - Form 483, 2001-07-31
February, 2002	FDA 483	Electric Mobility Corp - Form 483, 2002-02-01
August, 2008	EIR	Hassman, David, DO - EIR, 2008-08-14
August, 2015	FDA 483 Response	Tris Pharma Inc - Form 483R, 2015-08-27
September, 2007	FDA 483	Howard A. Hassman, DO - Form 483, 2007-09-26
February, 2002	EIR	Electric Mobility Corp - EIR, 2002-02-01
August, 2010	FDA 483	Perma Pure LLC - Form 483, 2010-08-23
April, 2012	FDA 483	Neurotron Medical Inc. - Form 483, 2012-04-27
October, 2007	FDA 483	Lucasti Christopher, D.O. - Form 483, 2007-10-26
February, 2003	EIR	Electric Mobility Corp - EIR, 2003-02-11
October, 2007	EIR	Lucasti Christopher, D.O. - EIR, 2007-10-26
September, 2007	EIR	Howard A. Hassman, DO - EIR, 2007-09-26
July, 2004	EIR	Hassman, David, DO - EIR, 2004-07-13
April, 2007	FDA 483	Lucasti Christopher, D.O. - Form 483, 2007-04-25
February, 2001	FDA 483	Pliva, Inc. - Form 483, 2001-02-05
April, 2014	FDA 483	Keystone Industries - Form 483, 2014-04-03
December, 2016	FDA 483	Eric Hansen - Form 483, 2016-12-21
April, 2014	FDA 483	MTI Precision Products LLC. - Form 483, 2014-04-30
April, 2009	FDA 483	Akers Biosciences, Inc. - Form 483, 2009-04-09
June, 2013	EIR	Xenobiotic Laboratories, Inc. - EIR, 2013-06-21
February, 2012	FDA 483	Arrow International, Inc. - Form 483, 2012-02-01
December, 2003	EIR	Dvorin, Donald Dr. - EIR, 2003-12-23
July, 2001	EIR	Berlin Medical Associates - EIR, 2001-07-31
July, 2008	FDA 483	Steven J. Glass, M.D. - Form 483, 2008-07-21
February, 2015	FDA 483	Prosec Protection Systems, Inc. - Form 483, 2015-02-25
February, 2006	FDA 483 Response	Ohm Laboratories Inc. - Form 483R, 2006-02-21
July, 2015	EIR	Kramer, Jeffery H., MD - EIR, 2015-07-15
June, 2009	FDA 483	EMD Millipore Corporation - Form 483, 2009-06-08
April, 2005	FDA 483	Arrow International, Inc. - Form 483, 2005-04-11
July, 2010	FDA 483	Biotech Atlantic, Inc. - Form 483, 2010-07-13
February, 2016	FDA 483	AtlantiCare Regional Medical Center IRB - Form 483, 2016-02-04
August, 2015	FDA 483	Tris Pharma Inc - Form 483, 2015-08-12
September, 2003	EIR	Product Safety Labs - EIR, 2003-09-29
March, 2011	FDA 483	Perma Pure LLC - Form 483, 2011-03-18
February, 2016	EIR	AtlantiCare Regional Medical Center IRB - EIR, 2016-02-04
June, 2013	FDA 483	Xenobiotic Laboratories, Inc. - Form 483, 2013-06-21
July, 2002	FDA 483	Cooper Health System IRB - Form 483, 2002-07-01
January, 2003	EIR	Howard A. Hassman, DO - EIR, 2003-01-16
April, 2014	FDA 483 Response	MTI Precision Products LLC. - Form 483R, 2014-05-16
May, 2013	EIR	Bristol-Myers Squibb Company - EIR, 2013-05-02
February, 2017	FDA 483	Lingraphicare America, Inc. - Form 483, 2017-02-15
October, 2015	FDA 483	Minta Medical Limited - Form 483, 2015-10-29
October, 2003	EIR	American Bio Medica Corporation - EIR, 2003-10-31
February, 2016	FDA 483 Response	AtlantiCare Regional Medical Center IRB - Form 483R, 2016-02-23
February, 2001	FDA 483	Mid-Atlantic Diagnostics - Form 483, 2001-02-26
April, 2013	FDA 483	Pharmaceutical Innovations, Inc. - Form 483, 2013-04-03
February, 2006	FDA 483	Ohm Laboratories Inc. - Form 483, 2006-02-10
October, 2016	EIR	PRA Health Sciences - EIR, 2016-10-20
July, 2008	EIR	Steven J. Glass, M.D. - EIR, 2008-07-21
November, 2002	FDA 483 Response	EMD Millipore Corporation - Form 483R, 2002-12-09
August, 2016	FDA 483	Colin Campbell - Form 483, 2016-08-29
June, 2013	FDA 483	Delva Tool & Machine Crp adba Delva Medical Technologies LLC - Form 483, 2013-06-06
January, 2013	FDA 483	Ossur Americas - Form 483, 2013-01-23

Experience Redica System's 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