FDA Investigator Edward J Janik

Edward J Janik has inspections in 15 countries as of 24 Oct 2023. Edward J Janik has collaborated with a combinined 3160 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
353
Last Inspection Date:
24 Oct 2023
Investigator Role:
FDA Investigator
Redica ID:
100000150
Country:
United States of America, Canada, Malaysia, United Kingdom of Great Britain and Northern Ireland, Italy, Germany, Russian Federation, India, Japan, Switzerland, Ireland, Israel, Spain, Taiwan
Co-Investigator(s):
A Williams, Alan R Condon, Alexander M Kay, Amy M Cramer, Ana P Barido, Andrea A Branche, Andrew Saunders, Angela Mock, Anthony C Warchut, Anthony N Onianwa, Arduino Frankovic, Arthur S Williams, Jr, Babatunde D Babalola, Benjamin J Dastoli, Brandy N Lepage, Brenna L Macdowell, Bryan J Love, Byungja E Marciante, Camerson E Moore, Carl Lee, Carr, Catherine J Laufmann, Chad E Schmear, Charles L Larson, Christine E Kelley, Christine L Williams, Christine M Smith, Christopher C Wilcox, Christopher Janik, Chunsheng Cai, PhD, Courtney N Long, Craig T Rybus, Daniel J Lahar, Danielle Larese, Darin S Wiegers, Daryl A Dewoskin, David P Vanhouten, Dawn M Braswell, Diane C Thibodeau, Dien N Nguyen, Dipesh K Shah, Dominic R Frasca, Dorothy W Lee, Dr. Sriram Subramaniam, PhD, Edmund F Mrak, Jr, Eduardo L Rodriguez, Edward D Mcdonald, Elizabeth B Griffin, Ellen J Tave, Emmanuel A Dimaano, Jr, Eric C Schmitt, Erin I Keith, Gabrielle J Swain, Gale E Ryan, Gary J Hagan, Gene R Gunn, George T Allen, Jr, Gerald T O'connor, Gerard D Difiore, Gerard J Desany, Hang N Guo, Harperd, Hasan A Irier, PhD, Jaclyn N Munsch, Jacqueline S Warner, James A Beaulieu, James M Kewley, James R Wormuth, James W Whitney, Janet B Abt, Janete F Guardia, Jeanne F Broderick, Jeffery A Hangartner, Jeffrey J Thibodeau, Jocelyn T Ramos, John A Hamilton, III, John A Hollings, John A Iwen, John A Sciacchitano, Jonah S Ufferfilge, Jonathan B Lewis, Jonathan G Matrisciano, Jorge E Martinez, Jose A Torres, Katarzyna Plona, Kent A Conforti, Kimberly Lewandowski Walker, Kimberly M White, Kirtida Patel, Kwong P Lee, Lance D Johnson, Lauren M Lawrance, Laurie B Frazier, LCDR Debra Emerson, LCDR Matthew J Morrison, LCDR Wilfred A Darang, Leighton K Ngai, Leonard H Lavi, Linda L Green, Lori A Holmquist, Lori S Lawless, Lucas B Leake, M Patriciaurphy Murphy, Margaret A Foster, Margaret M Sands, Maribeth G Niesen, Maricelys Mercado, Mark C Lookabaugh, Mark R Mcclain, Mary P Murphy, Maryam Tabatabaie, Matthew C Watson, Maura Rooney, Maya M Davis, Michael E Cimaglio, Michael G Mayfield, Michael J Leal, Michael P Anthony, Michael P Sweeney, Michelle J Glembin, Michelle M Noe, Mikayla K Deardorff, Minh D Phan, Mpris Inspector, Mutahar S Shamsi, Nealie C Newberger, Nina Yang, Paul A Licata, Paul E Stein, Paul P Geraci, Peter R Lenahan, Philip H Lafleur, Rafael A Kaup, Ralph Jerndal, Rapti D Madurawe, Rebecca B Welch, Richard F Hapke, Richard Jay Tucker, RS, Richard K Vogel, Richard L Licari, Robert E Davis, Robert E Teel, Robert G Antonsen, Jr, Robert J Martin, Roy Baby, Sam H Haidar, PhD, Sandra P White, Sarah A Hassas, Sarah Forney, Scott B Laufenberg, Scott K Zika, Scotty L Hargrave, Sean R Marcsisin, Sergio Chavez (NMI), Shawn M Bogdan, State Agency, Stephanie Mangigian, MS/OSH, RN, Stephen C Smith, Stephen D Eich, Stephen R Souza, Steven C Nattrass, Steven R Ziser, Suzie L Kent, Tania E Vizcaino, Tanya R Syffrard, Thai T Duong, Theressa B Smith, Thomas D Clarida, Todd D Alspach, Toni S Sturgis, Travis E Chapman, Troy R Petrillo, Victoria M Daddeo, Victoria Taylor, Wanda B Coats, William D Tingley, Xiaojun Yan, Yehualashet A Gessesse, Young M Choi, PhD, Yuan Fang

Edward J Janik's Documents

Publish Date Document Type Title
January, 2000 FDA 483 Endo Surgical Concepts, Inc. - Form 483, 2000-01-06
September, 2008 FDA 483 Contract Medical Manufacturing - Form 483, 2008-09-25
May, 2002 EIR Defibtech, LLC - EIR, 2002-05-01
December, 2002 FDA 483 Response Ultracell Medical Technologies, Inc. - Form 483R, 2003-01-07
March, 2000 FDA 483 Alan H.B. Wu., Ph.D. - Form 483, 2000-03-02
January, 2010 FDA 483 Brymill Corporation - Form 483, 2010-01-12
September, 2002 FDA 483 Response Wallach Surgical Devices, Inc. - Form 483R, 2002-10-10
August, 2004 FDA 483 Sekisui Diagnostics, LLC - Form 483, 2004-08-10
September, 2002 FDA 483 Wallach Surgical Devices, Inc. - Form 483, 2002-09-30
February, 2010 FDA 483 Z-Medica, LLC. (fully owned subsidiary Teleflex) - Form 483, 2010-02-02
October, 2011 EIR Medtronic, Ltd. - EIR, 2011-10-27
February, 2012 FDA 483 Response Covidien, LP - Form 483R, 2012-02-24
April, 2001 FDA 483 Aplicare Products, LLC - Form 483, 2001-04-26
July, 2002 EIR Edward M. Lane, M.D. - EIR, 2002-07-18
June, 2011 FDA 483 Covidien, LP - Form 483, 2011-06-16
May, 2009 FDA 483 Gaven Medical - Form 483, 2009-05-08
May, 2000 EIR Clinipad Corporation - EIR, 2000-05-24
December, 2002 FDA 483 Ultracell Medical Technologies, Inc. - Form 483, 2002-12-23
November, 2007 FDA 483 GyNova, LLC - Form 483, 2007-11-05
December, 2010 FDA 483 Hologic, Inc. - Form 483, 2010-12-15
November, 2002 EIR Diagnostic Oncology CRO, Inc. - EIR, 2002-11-14
November, 2009 FDA 483 Z-Medica, LLC. (fully owned subsidiary Teleflex) - Form 483, 2009-11-03
August, 2010 FDA 483 Defibtech, LLC - Form 483, 2010-08-18
March, 2010 FDA 483 Doctor's Research Group, Inc. - Form 483, 2010-03-04
February, 2007 EIR Pfizer Laboratories Div Pfizer Inc - EIR, 2007-02-07
February, 2012 FDA 483 Covidien, LP - Form 483, 2012-02-21

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