FDA Investigator Karen F Tomaziefski

Karen F Tomaziefski has conducted inspections on 88 sites in 1 countries as of 05 Jun 2007. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
88
Last Inspection Date:
05 Jun 2007
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Karen F Tomaziefski:
Allen Lou, Amy M Cramer, Ankur C Patel, Annemarie Bodnar, Anthony M Criscuolo, Jr, Antoinette L Ravelli, Barbara J Maulfair, Barbara Jwilimczyk Macri, Byungja E Marciante, Carol A Perry, Carol A Robles, Cary Greene, Celia L Hutchinstein, Charlotte P Chang, Craig W Swanson, Daniel W Johnson, David H Smith, David R Delucia, Denise M Digiulio, Derek S Dealy, Devon Jenkins, Dhaval H Patel, Diane B Radice, Doreen P Gubbay, Edward O'shaughnessy, Eric Rothschild, Frank J Marciniak, Gianine E Delade, Gianine E Tompkins, Gillian B Nardelli, Hitesh R Patel, James R Birkenstamm, Jason Kwong, Jean M Kelahan, Jennifer A Bazergui, Jessica M Monteiro, Jo Annc Declement, Joseph Duca, Joy F Canlas, Judith A Jones, Judith A Paterson, Karen M Ferguson, Keith A Schwartz, Keith M Reilly, Kerry A Kurdilla, Kinh Q Mac, Kris K Moore, Kristy A Zielny, Krystal O Ogunremi, Krystyna M Kitson, Kyle D Covill, Laishan L Lam, Lawrence Harmon, Jr, Lawrence R Johnson, Li Li, Lisa Harlan, Loretta Nemchik, Marcelo O Mangalindan, Jr, Marea K Harmon, Margaret M Sands, Marjorie D Schultz, Melissa B Libby, Meredith L Sheridan, Michael Rosner, Michelle L Johnson, Nancy M Espinal, Nerizza B Guerin, Nina Yang, Paterson, Paul L Bellamy, Ramanda C Gregory, Raymond L Cheung, Remache, Richard D Manney, Robert W Calais, Rodrigo Vilchez, Russell J Glapion, Sarah Forney, Schultz, Seng Ching Hwang, Sherri J Liu, Shirley S Wen, Sinai I Davis, Syeda N Mahazabin, Tara K Carmody, Teigan M Mule, Tiki J Dixon, Tressa T Lewis, Valerie C Reed, Wayne J Meyer, Whitney S Reynolds, William J Muszynski, William W Dotts, Willy A Orantes

Karen F Tomaziefski's Documents

Publish Date Document Type Title
May, 2003 EIR Sun Biomedical Laboratories, Inc. - EIR, 2003-05-05
August, 2001 EIR Akers Biosciences, Inc. - EIR, 2001-08-14
April, 2000 FDA 483 EMD Millipore Corporation - Form 483, 2000-04-05
March, 2003 FDA 483 EMD Millipore Corporation - Form 483, 2003-03-27
February, 2001 FDA 483 Mid-Atlantic Diagnostics - Form 483, 2001-02-26
November, 2002 FDA 483 Response EMD Millipore Corporation - Form 483R, 2002-12-09
June, 2003 FDA 483 Origio Inc. - Form 483, 2003-06-19
November, 2003 EIR Advanced Diagnostics, Inc. - EIR, 2003-11-18
April, 2000 EIR EMD Millipore Corporation - EIR, 2000-04-05
September, 2001 FDA 483 Miza Pharmaceuticals USA Inc. - Form 483, 2001-09-04
June, 2002 EIR Kimble Glass Inc - EIR, 2002-06-21
June, 2003 FDA 483 Response Origio Inc. - Form 483R, 2003-06-27
September, 2001 FDA 483 Electric Mobility Corp - Form 483, 2001-09-20
September, 2001 FDA 483 Response Electric Mobility Corp - Form 483R, 2001-09-21
September, 2001 EIR Electric Mobility Corp - EIR, 2001-09-20
July, 2000 EIR Electric Mobility Corp - EIR, 2000-07-27
December, 2000 FDA 483 Response J Lloyd Medical Inc - Form 483R, 2001-01-10
September, 2003 EIR Wheaton Industries Inc. - EIR, 2003-09-17
August, 2001 FDA 483 Response Akers Biosciences, Inc. - Form 483R, 2001-08-31
December, 2000 FDA 483 J Lloyd Medical Inc - Form 483, 2000-12-20
November, 2002 EIR EMD Millipore Corporation - EIR, 2002-11-26
April, 2000 FDA 483 Response EMD Millipore Corporation - Form 483R, 2000-04-18
February, 2000 FDA 483 Response Electric Mobility Corp - Form 483R, 2000-02-29
September, 2001 FDA 483 Response Miza Pharmaceuticals USA Inc. - Form 483R, 2001-10-12
July, 2003 FDA 483 Ossur Americas - Form 483, 2003-07-25
February, 2000 EIR Electric Mobility Corp - EIR, 2000-02-17
November, 2002 FDA 483 EMD Millipore Corporation - Form 483, 2002-11-26
July, 2000 FDA 483 Response Electric Mobility Corp - Form 483R, 2000-08-14
February, 2000 FDA 483 Electric Mobility Corp - Form 483, 2000-02-17
September, 2001 EIR Miza Pharmaceuticals USA Inc. - EIR, 2001-09-04
February, 2001 EIR Origio Inc. - EIR, 2001-02-26
November, 2003 FDA 483 Advanced Diagnostics, Inc. - Form 483, 2003-11-18
July, 2000 FDA 483 Electric Mobility Corp - Form 483, 2000-07-27
March, 2003 EIR EMD Millipore Corporation - EIR, 2003-03-27
May, 2006 FDA 483 St Jude Medical Inc - Form 483, 2006-05-03
June, 2003 EIR Origio Inc. - EIR, 2003-06-19
January, 2002 FDA 483 St Jude Medical Inc - Form 483, 2002-01-25
May, 2002 FDA 483 Fresenius Medical Care - Form 483, 2002-05-03
May, 2001 FDA 483 St Jude Medical Inc - Form 483, 2001-05-07
May, 2005 FDA 483 B. Braun Medical, Inc. - Form 483, 2005-05-23
July, 2004 EIR Hassman, David, DO - EIR, 2004-07-13

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.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

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