FDA Investigator Frank J Marciniak

Frank J Marciniak has inspections in 24 countries as of 29 Sep 2023. Frank J Marciniak has collaborated with a combinined 6041 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
355
Last Inspection Date:
29 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
100000185
Country:
United States of America, China, Germany, Italy, Switzerland, United Kingdom of Great Britain and Northern Ireland, Ireland, Mexico, Japan, New Zealand, Taiwan, Philippines, Denmark, Canada, Austria, France, Finland, Netherlands, Slovakia, Malaysia, Thailand, Spain, Czechia
Co-Investigator(s):
A Williams, Aaron L Dunbar, Adam S Freeman, Addam S Reynolds, Adetutu M Gidado, Akbar J Zaidi, Alberto A Viciedo, Alexandra A Carrico, Alice S Tsao, Allen Lou, Alois P Provost, Althea A Williams, Amanda Dinaro, Amy L Singer, Amy M Cramer, Ana S Cabrera, Ankur C Patel, Ann Marie Montemurro, Annemarie B Randow, Annemarie Bodnar, Anthony J Donato, Anthony M Criscuolo, Jr, Arthur S Williams, Jr, Ashley J Burns, Atul J Agrawal, Barbara J Maulfair, Barbara Jwilimczyk Macri, Benjamin J Dastoli, Bill Tacket, Jr, Billi Jom Johnson, Brenda L Reihing, Brian S Keefer, Brigitte K Hofmann, Brigitte Kh Strelnik, Burnell M Henry, Byungja E Marciante, Carl A Perez, Cary Greene, Catherine J Laufmann, CDR Sean T Creighton, Charles J Chacko, Charles L Larson, Cheryl D Mccall, Christina N Maurino, Christine M Cerenzio, Claudette D Brooks, Colin E Tack, Craig W Swanson, Cynthia Jim, CSO, Cynthia L Gorveatt, Cynthia R Gibson, Daniel J Grabicki, Daniel J Lahar, Daniel L Aisen, Daniel S Fam, Darla J Christopher, Dave M Deroche, David H Smith, David J Gomes, David P Vanhouten, Dawn L Wydner, Dawn M Braswell, Deborah A Nebenzahl, Deborah B Nixon, Denise M Visco, Investigator, Dennis E Guilfoyle, PhD, Dennis G Kawabata, Dhaval H Patel, Diane B Radice, Dianiris C Ayala, Dipesh K Shah, Donna Ltartaglino Besone, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovace, Douglas C Kovacs, Dr. Guang Gao, PhD, Edmund F Mrak, Jr, Edward D Mcdonald, Edward Oshaughnessy, Eileen A Liu, Eliezar Ramos, Elizabeth D Connell, Emest F Bizjak, Emmanuel J Ramos, Eric J Cunningham, Eric M Padgett, Eric Rothschild, Eric S Pittman, Erica M Katherine, Erin D Mccaffery, Erin L Mcfiren, Esteban Beltran, Evelyn Taha, Felix J Marrero, Francis J Eng, Frank J Marci, Frank J Mariciniak, Frederick Razzaghi, Gail L Katz, Gamal A Norton, Gene D Arcy, George T Allen, Jr, Gerald D Bromley, Jr, Gianine E Delade, Gobiga Vanniyasingam, Gregson A Joseph, Guerlain Ulysse, Harperd, Harry J Brewer, Helen B Ricalde, Helen Verdel, Herrmann, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James E Frye, James H Robinson, James M Odonnell, James M Simpson, James P Mcreavey, James R Birkenstamm, James R Montero, James W Plucinski, Jane R Donnelly, Janet B Abt, Janet Pulver, Janete A Eaker, Janete A Oliveira, Janete F Guardia, Janice L King, Jason M Sluzynski, Javonica F Penn, Jean M Kelahan, Jennifer A Bazergui, Jennifer L Custodio, Jennifer M Menendez, Jennifer Macmillan, Jesse A Vazquez, Jessica M Monteiro, Jocelyn E Massey, Jocelyn M Muggli, Jogy George, John A Sciacchitano, John M Seale, Jonathan B Lewis, Jonathan Ho, Jonee J Mearns, Jose M Cayuela, Joseph Duca, Joseph F Mcginnis, RPh, Joseph L Despins, PhD, Joshua C Schafer, Joshua J Silvestri, Joy F Canlas, Joy Rkozlowski Klena, Judy Strojny Not In Use, Julie D Bringger, Justine Tomasso, Karen A Briggs, Karen A Coleman, Karen E D'orazio, Karen F Tomaziefski, Karen S Anthony, Katherine E Jacobitz, Kazi Rafiquzzaman, Keith M Reilly, Kelli F Dobilas, Kelli F Regenye, Kelly Doremus, Kelly I Anderson, Kelvin Cheung, Kerry A Kurdilla, Kham Phommachanh, King, Kinh Q Mac, Kristen E Rescigno, Kristy A Zielny, Ladislav Kermet, Laishan L Lam, Laureen M Geniusz, Lauren L Vajo, Lauren M Lawrance, Lauren M Mclaughlin, Laurie A Haxel, Laurie B Frazier, Laurimer Kuilan Torres, Lawrence R Johnson, LCDR Debra Emerson, LCDR Wilfred A Darang, Leo J Lagrotte, Leonard H Lavi, Leslie R Clark, Li Li, Liatte Kreuger, PharmD, Linda Agregory Duty, Linda S Mattingly, Lisa B Hall, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Lori A Carr, LT Tamara J Henderson, Lydia S Chan, Malik S Qaiser, Marcellinus D Dordunoo, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Maria Estrella, Marjorie D Schultz, Mark E Chan, Martha T Olone, Matthew D Schnittker, Matthew W Kyle, Mei Chen Mu, Meihong Liu, Melanie W Pishnery, Melba T Rivera, Melba Trivera Clavell, Melissa A Freeman, Melissa A Zuppe, Melissa B Libby, Melissa T Roy, Melka F Argaw, Meredith L Sheridan, Michael A Taylor, Michael J Nerz, Michael R Klapal, Michael Rosner, Michael Serrano, Michele Gottshall, Michelle J Glembin, Michelle L Johnson, Michelle M Parisi, Miguel G Manzano, Miguel Gmanzano Maldonado, Mihaela Jason, Mike M Rashti, Mishelle L Harriger, Mizanne E Lewis, Monica L Gutierrez, Monika Borkowska, Naakesh N Gomanie, Nadeem I Chaudhry, Nancy F Scheraga, Nancy L Neiger, Nancy L Rolli, Nancy M Espinal, Nathaniel R Esaw, Nerizza B Guerin, Nicholas A Vicland, Nicholas A Violand, Nicholas C Mendiola, Niketa Patel, Nikki S Ramirez, Nydia E Colon, Omotunde O Osunsanmi, Paige E Shelborne, Paige E Wilson, Parul M Patel, Paul E Stein, Paul L Bellamy, Paul R Whitby, Paula A Trost, Pauline N Logan, Perry H Gambrell, Peter R Lenahan, Phares O Okelo, Phillip M Pontikos, Prabhu P Raju, Raffi B Papazian, Ralph Jerndal, Raymond L Cheung, Regina T Brown, Remache, Richard D Manney, Richard Jay Tucker, RS, Richard L Rutherford, Robert G Ruff, Robert S Sweeton, Ronald Ifraimov, Rosanna M Goodrich, Rose Ashley, Rose Ljean Mary, Rose M Ashley, Roy Baby, Russell J Glapion, Saleem A Akhtar, Sandra Kershaw, Sarah A Hassas, Sarah Forney, Sargum C Sood, Schultz, Scott R Izyk, Seema S Singh, Selene T Torres, Shafiq S Ahadi, Sharmila Shrestha, Sherri J Liu, Sherry G Bous, Shirley S Wen, Simone E Pitts, Sinai Davis, Stanley B Eugene, BS, BME, State Agency, Stephanie T Durso, Stephen C Smith, Stephen D Eich, Stephen J Mottola, Stephen R Souza, Steven E Kane, Steven M Weinman, Steven R Ziser, Steven S Wahl, Susan M Jackson, Susan M Matthias, Tania E Garcia, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Teresa Jimenez, Teresita C Mercado, Thai T Duong, Thomas A Peter, Thomas E Friel, Thomas J Arista, Tonia F Bernard, Tony T Yang, Tracey L Harris, Travis S Bradley, Tressa T Lewis, Valerie C Reed, Valerie Reed, Victor Spanioli, Vivian Garcia, Wei Wang, PhD, Wendy R Blame, William R Chang, Xiaojun Yan, Xiaoping Guan, Xiuju Lu, Yehualashet A Gessesse, Yung W Chan, Yvesna C Blaise, Yvette Mlacour Davis, Yvins Dezan, Zakaria I Ganiyu

Frank J Marciniak's Documents

Publish Date Document Type Title
May, 2013 FDA 483 Ulrich Gmbh & Co. KG - Form 483, 2013-05-03
December, 2003 FDA 483 Response Genzyme Corporation - Form 483R, 2004-01-15
March, 2014 EIR Johnson & Johnson Consumer, Inc. - EIR, 2014-03-10
February, 2012 EIR 3shape A/S - EIR, 2012-02-09
March, 2000 FDA 483 Response Siemens Industry, Inc. - Form 483R, 2000-03-31
February, 2000 EIR Shelhigh, Inc. - EIR, 2000-02-09
September, 2001 EIR CFH Laboratories LP - EIR, 2001-09-27
March, 2000 EIR Becton Dickinson & Company - EIR, 2000-03-31
January, 2010 FDA 483 Scimedx Corporation - Form 483, 2010-01-22
June, 2003 EIR Oticon Inc. - EIR, 2003-06-30
February, 2001 EIR Pacon Manufacturing Corporation - EIR, 2001-02-26
September, 2001 FDA 483 CFH Laboratories LP - Form 483, 2001-09-27
April, 2023 FDA 483 Artegraft, Inc. - Form 483, 2023-04-13
June, 2002 EIR Reed-Lane, Inc. - EIR, 2002-06-06
August, 2003 FDA 483 EUROMED, INC. - Form 483, 2003-08-01
July, 2009 FDA 483 Cath-Labs Corp. - Form 483, 2009-07-10
October, 2013 FDA 483 Maquet Cardiovascular, LLC - Form 483, 2013-10-16
June, 2018 FDA 483 Response Datascope Corp. - Form 483R, 2018-07-02
February, 2000 FDA 483 Shelhigh, Inc. - Form 483, 2000-02-09
June, 2014 FDA 483 Valeant Pharmacueticals North America LLC - Form 483, 2014-06-26
February, 2023 FDA 483 Almark Tool & Manufacturing Company, Inc. - Form 483, 2023-02-07
October, 2021 FDA 483 Next Medical Products Company, LLC - Form 483, 2021-10-04
June, 2023 FDA 483 Navinta LLC - Form 483, 2023-06-29
November, 2001 FDA 483 Howmedica Osteonics Corp - Form 483, 2001-11-07
December, 2003 FDA 483 Genzyme Corporation - Form 483, 2003-12-09
June, 2021 FDA 483 Svelte Medical Systems - Form 483, 2021-06-14
May, 2013 FDA 483 DOT Gmbh - Form 483, 2013-05-16
July, 2012 FDA 483 Hangzhou Jinlin Medical Appliances Co., Ltd. - Form 483, 2012-07-26
January, 2013 FDA 483 Pajunk GmbH - Form 483, 2013-01-31
July, 2022 FDA 483 Light Age, Inc. - Form 483, 2022-07-01
June, 2003 FDA 483 Artegraft, Inc. - Form 483, 2003-06-10
September, 2016 FDA 483 Maquet Medical Systems USA - Form 483, 2016-09-29
March, 2000 FDA 483 Becton Dickinson & Company - Form 483, 2000-03-31
March, 2002 FDA 483 CFH Laboratories LP - Form 483, 2002-03-14
December, 2012 FDA 483 GS Medical Co., Ltd. - Form 483, 2012-12-13
March, 2014 FDA 483 Johnson & Johnson Consumer, Inc. - Form 483, 2014-03-10
January, 2013 EIR Pajunk GmbH - EIR, 2013-01-31
December, 2004 FDA 483 Nobel Biocare Procera, Inc. - Form 483, 2004-12-09
October, 2009 FDA 483 Unit Pack Co., Inc. - Form 483, 2009-10-26
August, 2003 EIR EUROMED, INC. - EIR, 2003-08-01
August, 2019 FDA 483 Water-Jel Technologies - Form 483, 2019-08-15
August, 2003 FDA 483 Response EUROMED, INC. - Form 483R, 2003-10-07
June, 2018 FDA 483 Datascope Corp. - Form 483, 2018-06-11
August, 2003 EIR Physitemp Instruments, LLC - EIR, 2003-08-29
October, 2000 FDA 483 Boston Scientific Corp. - Form 483, 2000-10-24
September, 2015 FDA 483 Excelsior Medical LLC - Form 483, 2015-09-29
May, 2014 FDA 483 Therakos, Inc. - Form 483, 2014-05-07
October, 2000 EIR Boston Scientific Corp. - EIR, 2000-10-24
November, 2001 FDA 483 Howmedica Osteonics Corp - Form 483, 2001-11-07
December, 2000 FDA 483 Response Shelhigh, Inc. - Form 483R, 2000-12-20
March, 2014 FDA 483 Response Johnson & Johnson Consumer, Inc. - Form 483R, 2014-03-26
December, 2011 FDA 483 Osypka Medical Gmbh - Form 483, 2011-12-01
September, 2016 FDA 483 Maquet Cardiovascular, LLC - Form 483, 2016-09-29
April, 2003 EIR International Technidyne Corp. - EIR, 2003-04-14
December, 2000 FDA 483 Shelhigh, Inc. - Form 483, 2000-12-18
July, 2015 FDA 483 Valeant Pharmacueticals North America LLC - Form 483, 2015-08-31
October, 2022 FDA 483 UMI Intl - Form 483, 2022-10-20
October, 2012 FDA 483 Oy Ajat Ltd - Form 483, 2012-10-11
May, 2003 EIR Zeus Scientific, Inc. - EIR, 2003-05-13
October, 2014 FDA 483 Prosec Protection Systems, Inc. - Form 483, 2014-10-10
October, 2000 FDA 483 Response Boston Scientific Corp. - Form 483R, 2000-10-27
April, 2005 FDA 483 Bio Compression Systems, Inc. - Form 483, 2005-04-22
November, 2002 EIR Isotron Plc - EIR, 2002-11-20
July, 2001 FDA 483 ACUPAC PACKAGING INC - Form 483, 2001-07-10
February, 2012 FDA 483 BTS S.p.A. - Form 483, 2012-02-02
November, 2017 FDA 483 Immunostics, Inc. - Form 483, 2017-11-08
March, 2023 FDA 483 Enterix, Inc. - Form 483, 2023-03-10
March, 2000 FDA 483 United States Filter Corporation - Form 483, 2000-03-17
February, 2017 FDA 483 AMD Medicom Inc. (GRANBY PLANT) - Form 483, 2017-02-09
August, 2017 FDA 483 LifeCell Corporation - Form 483, 2017-08-25
May, 2003 FDA 483 Response Zeus Scientific, Inc. - Form 483R, 2003-05-30
July, 2009 FDA 483 Buxton Biomedical Inc - Form 483, 2009-07-27
August, 2000 EIR Datascope Corp. - EIR, 2000-08-03
May, 2012 FDA 483 ENERGIST LIMITED - Form 483, 2012-05-24
March, 2020 FDA 483 Light Age, Inc. - Form 483, 2020-03-11
February, 2003 EIR Collagen Matrix, Inc. - EIR, 2003-02-11
April, 2002 FDA 483 Boston Scientific Corp. - Form 483, 2002-04-04
September, 2022 FDA 483 Alfa Wassermann, Inc. - Form 483, 2022-09-27
April, 2002 EIR Boston Scientific Corp. - EIR, 2002-04-04
July, 2012 FDA 483 Shanghai Ruike Sports Goods Co., LTD. - Form 483, 2012-07-19
March, 2022 FDA 483 Angel Medical Systems, Inc. - Form 483, 2022-03-28
March, 2010 FDA 483 Diopsys, Inc. - Form 483, 2010-03-01
June, 2014 FDA 483 Response Valeant Pharmacueticals North America LLC - Form 483R, 2014-07-14
April, 2009 FDA 483 Cargille-Sacher Laboratories Inc. - Form 483, 2009-04-16
May, 2005 FDA 483 Response Shelhigh, Inc. - Form 483R, 2005-06-06
May, 2003 FDA 483 Zeus Scientific, Inc. - Form 483, 2003-05-13
May, 2013 FDA 483 ITALIA MEDICA S.R.L. - Form 483, 2013-05-09
July, 2003 EIR Medtronic Paceart - EIR, 2003-07-22
September, 2001 FDA 483 Response CFH Laboratories LP - Form 483R, 2001-12-14
May, 2012 FDA 483 Intersurgical Ltd. - Guernsey - Form 483, 2012-05-17
February, 2000 FDA 483 Response Shelhigh, Inc. - Form 483R, 2000-02-22
April, 2002 FDA 483 Response Boston Scientific Corp. - Form 483R, 2002-04-29
February, 2021 FDA 483 Maquet Cardiovascular, LLC - Form 483, 2021-02-26
November, 2001 EIR Howmedica Osteonics Corp - EIR, 2001-11-07
August, 2021 FDA 483 Water-Jel Technologies - Form 483, 2021-08-18
June, 2003 EIR Artegraft, Inc. - EIR, 2003-06-10
August, 2014 FDA 483 Excelsior Medical LLC - Form 483, 2014-08-21
August, 2022 FDA 483 Alkaline Corporation - Form 483, 2022-08-16
August, 2003 FDA 483 Physitemp Instruments, LLC - Form 483, 2003-08-29
October, 2000 FDA 483 Nexcore Technology, Inc. - Form 483, 2000-10-16
January, 2015 FDA 483 Artegraft, Inc. - Form 483, 2015-01-28
May, 2009 FDA 483 Bloomex International, Inc. - Form 483, 2009-05-01
December, 2003 EIR Genzyme Corporation - EIR, 2003-12-09
January, 2005 FDA 483 Genzyme Corporation - Form 483, 2005-01-20
April, 2022 FDA 483 Quadm Technologies, Llc - Form 483, 2022-04-25
March, 2008 FDA 483 Gomez Packaging Corp - Form 483, 2008-03-20
June, 2009 FDA 483 D.M. Davis Incorporated - Form 483, 2009-06-09
April, 2002 EIR Cosmed of New Jersey - EIR, 2002-04-02
April, 2011 FDA 483 Procon Medizintechnik GmbH - Form 483, 2011-04-06
June, 2003 FDA 483 Oticon Inc. - Form 483, 2003-06-30
May, 2015 FDA 483 Alto Development Corp - Form 483, 2015-05-29
June, 2019 FDA 483 LifeCell Corporation - Form 483, 2019-06-14
March, 2009 FDA 483 Case Medical, Inc. - Form 483, 2009-03-24
March, 2015 FDA 483 Burpee Materials Technology, LLC - Form 483, 2015-03-16
June, 2003 FDA 483 Response Artegraft, Inc. - Form 483R, 2003-07-25
April, 2015 FDA 483 Sivantos (Suzhou) Co., Ltd. - Form 483, 2015-04-16
May, 2005 FDA 483 Shelhigh, Inc. - Form 483, 2005-05-16
October, 2018 FDA 483 Datascope Corp. - Form 483, 2018-10-03
June, 2014 FDA 483 Nano-Ditech Corporation - Form 483, 2014-06-03
April, 2011 FDA 483 Advanced Medical Technologies AG - Form 483, 2011-04-07
April, 2011 EIR Alcon Grieshaber AG - EIR, 2011-04-14
November, 2001 EIR Howmedica Osteonics Corp - EIR, 2001-11-07
October, 2000 EIR Cosmed of New Jersey - EIR, 2000-10-23
December, 2000 EIR Shelhigh, Inc. - EIR, 2000-12-18
March, 2000 EIR Siemens Industry, Inc. - EIR, 2000-03-17
November, 2022 FDA 483 Pausch LLC - Form 483, 2022-11-09
February, 2018 FDA 483 TYRX Inc. - Form 483, 2018-02-27
August, 2023 FDA 483 Aeton Medical - Form 483, 2023-08-09
August, 2023 FDA 483 Microcision Llc - Form 483, 2023-08-09
May, 2023 FDA 483 Sterigenics US LLC - Form 483, 2023-05-31

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