FDA Investigator Marea K Harmon

Marea K Harmon has conducted inspections on 88 sites in 1 countries as of 28 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:
28 Jun 2007
Investigator Role:
FDA Investigator
Redica ID:
100008022
Countries of Inspections:
United States of America
FDA Investigators that have inspected at least one site in common with Marea K Harmon:
Addam S Reynolds, Adetutu M Gidado, Amy Chen, Amy L Singer, Amy M Cramer, Amy N Chen, Anastasia M Shields, Anita R Michael, Ankur C Patel, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Anthony J Donato, Ashutosh Rao, PhD, Atul J Agrawal, Audrey Thereset Uy, Azeezat M Lawal, Barbara Jwilimczyk Macri, Bei Yu, Brandon M Kurjanowicz, Byungja E Marciante, Cary Greene, Charles M Edwards, Christian F Gomez Lugo, Christina K Theodorou, Christina P Burkhart, Colleen M Damon, Craig D Zagata, Cynthia F Kleppinger, MD, Daniel J Grabicki, Darren S Morgan, David A Oluwo, Dawn L Wydner, Debra J Bennett, Denise M Digiulio, Denise M Visco, Investigator, Devon Jenkins, Diane M Gubernot, Donald C Obenhuber, PhD, Donald L Lech, Dorothy J Denes, Douglas C Kovacs, Edmund F Mrak, Jr, Emest F Bizjak, Emmanuel Jramos Maldonado, Eric Rothschild, Frank J Marciniak, Frederick F Razzaghi, Gary C Pecic, Jr, Gayle S Lawson, George Pyramides, Grace I Cortesini, Guerlain Ulysse, Hector A Carrero, Helen B Ricalde, Jaison J Eapen, James A Liubicich, James C Illuminati, James R Birkenstamm, Jay B Shah, Jay T Wong, Jean Blackston Hill, Jean M Mulinde, MD, Jennifer L Custodio, Jennifer Macmillan, Jessica M Monteiro, Jo Annc Declement, Joanne Heim, Joanne M Hajoway, Jonathan G Matrisciano, Jonee J Mearns, Jose M Cayuela, Joshua C Schafer, Joy Rkozlowski Klena, Juanita P Versace, Judith A Paterson, Julianne C Mccullough, Justine Tomasso, Karen A Briggs, Karen E D'orazio, Karen F Tomaziefski, Karen M Ferguson, Karishma G Gopaul, Karyn M Campbell, Kelli F Dobilas, Kenneth M Gordon, Kevin Obrien, Kevin P Foley, Ko U Min, Kristen D Evans, Kristen E Rescigno, Kristina J Donohue, Kristina L Conroy, Kristina Mjoyce Pittman, Kristy A Zielny, Krystyna M Kitson, Kurt A Brorson, PhD, Lauren L Vajo, Leanna M Slarsky, Li Li, Lisa B Orr, Lisa Harlan, Lisa M Bellows, Loretta Nemchik, Lori M Newman, LT Colin E Tack, BSE, Luella J Rossi, Luis A Dasta, Margaret M Sands, Maria A Bienkowski, Maria A Reed, Maria Estrella, Matthew R Noonan, Melissa B Libby, Meredith L Sheridan, Meyer J Slobotsky, Michael Gurbarg, Michael L Casner, Michael R Klapal, Michael Serrano, Michele M Falchek, Michelle M Parisi, Mina D Ahmadi, Monika Borkowska, Nancy L Rolli, Nancy M Espinal, Nerizza B Guerin, Nicholas A Violand, Nikki S Ramirez, Nina Yang, Odera I Ekwunife, Paul L Bellamy, Peter R Lenahan, Phares O Okelo, Puspa Suresh Jayasekara, Rachael O Oyewole, Ramanda C Gregory, Raymond L Cheung, Regina T Brown, Richard E Needham, Robert B Shibuya, MD, Robert J Maffei, Rochelle L Cross, Rosario D'costa, Rose Xu, Russell J Glapion, Rw Mccullough, Sam Pepe, Sarah Adella Fave, Sarah Forney, Sean G Casey, Sean R Marcsisin, Seng Ching Hwang, Sharon K Thoma, PharmD, Shirley H Isbill, Shirley S Wen, Stephanie Mangigian, MS/OSH, RN, Stephen J Koniers, Susan F Laska, MS, Tamil Arasu, PhD, Tammy L Chavis, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Temar Q Williams, Thomas E Friel, Tonia F Bernard, Unnee Ranjan, Vlada Matusovsky, Wayne J Meyer, Ying Zhang, Yoriann M Cabrera Bartolomei, Yvesna C Blaise

Marea K Harmon's Documents

Publish Date Document Type Title
July, 2005 FDA 483 Able Laboratories, Inc. - Form 483, 2005-07-06
August, 2001 FDA 483 Response Advent Pharmaceuticals Inc. - Form 483R, 2002-01-30
March, 2005 EIR AAA Pharmaceutical, Inc. - EIR, 2005-03-08
June, 2006 FDA 483 Guardian Drug Company - Form 483, 2006-06-12
January, 2002 FDA 483 Specialty Packaging LLC - Form 483, 2002-01-29
September, 2002 FDA 483 Siegfried USA, LLC - Form 483, 2002-09-24
October, 2001 EIR Hikma Pharmaceuticals USA Inc. - EIR, 2001-10-22
December, 2006 FDA 483 EPR Industries, Inc. - Form 483, 2006-12-28
February, 2004 EIR Able Laboratories Inc. - EIR, 2004-02-04
February, 2002 FDA 483 Sandoz Inc. - Form 483, 2002-02-22
May, 2003 EIR Ohm Laboratories Inc - EIR, 2003-05-20
September, 2002 EIR Siegfried USA, LLC - EIR, 2002-09-24
June, 2002 FDA 483 AAA Pharmaceutical, Inc. - Form 483, 2002-06-25
December, 2001 FDA 483 Response Ecolab Inc - Form 483R, 2002-01-16
May, 2001 EIR IGI, Inc. - EIR, 2001-05-30
November, 2006 FDA 483 Meda Pharmaceuticals, Inc. - Form 483, 2006-11-07
May, 2001 EIR Hikma Pharmaceuticals USA Inc. - EIR, 2001-05-21
June, 2004 FDA 483 Response WuXi Advanced Therapies Inc. - Form 483R, 2004-07-06
February, 2004 FDA 483 Able Laboratories Inc. - Form 483, 2004-02-04
August, 2001 FDA 483 Neil Laboratories Inc. - Form 483, 2001-08-10
April, 2006 FDA 483 Hikma Pharmaceuticals USA Inc. - Form 483, 2006-04-13
November, 2006 EIR Meda Pharmaceuticals, Inc. - EIR, 2006-11-07
December, 2003 EIR Sterigenics U.S., LLC - EIR, 2003-12-04
August, 2001 EIR Advent Pharmaceuticals Inc. - EIR, 2001-08-10
February, 2001 FDA 483 Janssen Pharmaceuticals, Inc. - Form 483, 2001-02-15
April, 2003 EIR Janssen Pharmaceuticals, Inc. - EIR, 2003-04-09
February, 2001 EIR Janssen Pharmaceuticals, Inc. - EIR, 2001-02-15
September, 2001 FDA 483 Accumed, Inc. - Form 483, 2001-09-28
February, 2007 FDA 483 Renaissance Lakewood LLC - Form 483, 2007-02-23
May, 2002 EIR CMIC CMO USA CORP - EIR, 2002-05-29
June, 2003 EIR TPM Laboratories, Inc. - EIR, 2003-06-25
May, 2002 EIR Hikma Pharmaceuticals USA Inc. - EIR, 2002-05-08
September, 2002 FDA 483 Response Siegfried USA, LLC - Form 483R, 2002-10-09
January, 2003 EIR Veranova, L.P. - EIR, 2003-01-31
June, 2004 EIR WuXi Advanced Therapies Inc. - EIR, 2004-06-03
April, 2003 EIR Hikma Pharmaceuticals USA Inc. - EIR, 2003-04-29
June, 2004 FDA 483 WuXi Advanced Therapies Inc. - Form 483, 2004-06-03
May, 2001 FDA 483 Hikma Pharmaceuticals USA Inc. - Form 483, 2001-05-21
December, 2001 FDA 483 Ecolab Inc - Form 483, 2001-12-11
September, 2006 FDA 483 Davlyn Industries Inc. - Form 483, 2006-09-22
March, 2001 EIR Lawson Mardon Wheaton (Glass) - EIR, 2001-03-08
November, 2006 FDA 483 Response Meda Pharmaceuticals, Inc. - Form 483R, 2006-12-01
August, 2006 FDA 483 Leak Detection Associates Inc - Form 483, 2006-08-31
December, 2001 EIR Ecolab Inc - EIR, 2001-12-11

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