FDA Investigator Kinh Q Mac

Kinh Q Mac has conducted inspections on 192 sites in 11 countries as of 25 Apr 2011. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
192
Last Inspection Date:
25 Apr 2011
Investigator Role:
FDA Investigator
Redica ID:
100004589
Countries of Inspections:
Italy, United States of America, Switzerland, Ireland, Sweden, Denmark, Finland, Germany, United Kingdom of Great Britain and Northern Ireland, France, Netherlands
FDA Investigators that have inspected at least one site in common with Kinh Q Mac:
Aaron L Dunbar, Addam S Reynolds, Alberto A Viciedo, Allen Lou, Althea A Williams, Amatul H Marium, Amy L Singer, Amy M Codella, Amy M Cramer, Amy S Graf, Ana S Cabrera, Andrea A Branche, Andrew H Paeng, Ann Marie Montemurro, Annemarie B Randow, Annemarie Bodnar, Annet R Rajan, Anthony M Criscuolo, Jr, Art O Czabaniuk, Arthur S Williams, Jr, Ashley A Mutawakkil, Atul J Agrawal, Barbara D Wright, Barbara J Maulfair, Barbara Jwilimczyk Macri, Benjamin J Dastoli, Benjamin J Smith, Benjamin W Anderson, Brian S Keefer, Brittany M Lowe, Burnell M Henry, Byungja E Marciante, Calvin K Cook, Carl A Perez, Cary Greene, Catherine J Laufmann, CDR Sean T Creighton, Charles J Chacko, Charles M Spyr, Charles N Dupont, Christian D Lynch (CDL), Christina L Bigham, Christina N Maurino, Corrine M Carter, Cynthia A Harris, MD, RN, Cynthia L Aycock, Cynthia Li, Daniel J Grabicki, Daniel L Aisen, Dave M Deroche, David H Smith, David J Gasparovich, Dawn L Wydner, Debara R Reese, Deborah B Nixon, Dennis E Guilfoyle, PhD, Dennis R Hock, Dhaval H Patel, Dolores Harper, Doreen P Canetti, Doreen P Gubbay, Dorothy J Denes, Douglas C Kovacs, Dr. Guang Gao, PhD, Dr. Nallaperumal Chidambaram, Edward D Mcdonald, Edward O'shaughnessy, Eileen A Liu, Elizabeth D Connell, Emest F Bizjak, Emily J Orban, Emmanuel Jramos Maldonado, Eric J Cunningham, Eric M Padgett, Eric Rothschild, Eric S Pittman, Eric W Anderson, Erin D Mccaffery, Esteban Beltran, Evelyn Taha, Felix J Marrero, Frank J Marciniak, Frederick F Razzaghi, Fulton A Varner, Gamal A Norton, Gary Durbiel Goldner, George G Calafactor, George Pyramides, George T Allen, Jr, Gianine E Tompkins, Gobiga Vanniyasingam, Gregson A Joseph, Guerlain Ulysse, Helen B Ricalde, Helen Verdel, Hitesh R Patel, Jacob M Dyer, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James A Beaulieu, James E Szelc, James L Finn, James M Odonnell, Jason M Sluzynski, Jean Blackston Hill, Jean M Kelahan, Jennifer Macmillan, Jessica S Estriplet, Jocelyn C Turner, Jogy George, Jonathan Ho, Jonee J Mearns, Jose M Cayuela, Joseph F Mcginnis, RPh, Joseph L Despins, PhD, Joseph R Strelnik, Joy Rkozlowski Klena, Jude C Dikes, Juliane C Lessard, Justine Tomasso, K Gonzlez, Karen E D'orazio, Karen F Tomaziefski, Keith M Reilly, Kelli F Dobilas, Kelly Doremus, Kelly I Anderson, Kennita Riddick, Kerry A Kurdilla, Kimberly Lewandowski Walker, Kristen E Rescigno, Kristy A Zielny, Kwong P Lee, Laishan L Lam, Lance D Johnson, Larry K Austin, Laureen M Geniusz, Lauren E Burke, Lauren E Sexton, Lauren L Vajo, Lawton W Lum, LCDR Anastasia M Piliafas Brown, Leo J Lagrotte, Leonard H Lavi, Li Li, Liatte Kreuger, PharmD, Lisa Harlan, Lisa Mathew, Loretta Nemchik, Lori A Carr, Lori S Lawless, LT Colin E Tack, BSE, Lydia S Chan, Marcelo O Mangalindan, Jr, Margaret M Sands, Maria Estrella, Marjorie D Schultz, Mark E Chan, Mark E Parmon, Marlo Ianm Alintanahin, Martha T Olone, Maryam Tabatabaie, Matthew W Kyle, Melanie W Pishnery, Melba Trivera Clavell, Melina Lrodriguez Upton, Melissa A Freeman, Melissa A Zuppe, Melissa T Roy, Meredith L Sheridan, Meyer J Slobotsky, Michael A Taylor, Michael J Nerz, Michael O Idowu, Michael R Klapal, Michael Serrano, Michelle J Glembin, Michelle L Johnson, Miguel Gmanzano Maldonado, Minerva Rogers, Mishelle L Harriger, Monica J Wilkins, Monica L Gutierrez, Msdap Gonzlezk, Myra K Casey, Naakesh N Gomanie, Nancy L Rolli, Nancy M Espinal, Nerizza B Guerin, Nicholas A Violand, Nikki S Ramirez, Nina Yang, Nisha C Patel, Norman Wong, Omotunde O Osunsanmi, Paige R Mccoy, Patrick B Cummings, Paul E Stein, Paul L Bellamy, Paul M Kawamoto, Paul W Moy, Paula A Trost, Pauline N Logan, Peter R Lenahan, Phillip M Pontikos, Prabhu P Raju, Preston M Lee, Raffi B Papazian, Raihan A Chowdhury, Ralph Jerndal, Raymond L Cheung, Rebecca Rodriguez, Regina T Brown, Reginald Walker, Remache, Richard D Manney, Richard L Rutherford, Richard T Riggie, Ricki A Chase, Robert G Ruff, Robert J Maffei, Rosanna M Goodrich, Rose Ashley, Rose Ljean Mary, Russell J Glapion, Ryan J Benedict, Samuel L Murray, Sandra Kershaw, Sarah Adella Fave, Sarah Forney, Sargum C Sood, Schultz, Sean G Casey, Sherri J Liu, Sherry G Bous, Shirley H Isbill, Shirley S Wen, Simone E Pitts, Sinai I Davis, Stephanie T Durso, Stephen D Eich, Stephen J Mottola, Stephenie M Ortiz, Steven M Weinman, Steven R Ziser, Susan D Yuscius, Susan M Halsted, Susan M Jackson, Suyang Qin, Tania E Garcia, Tania E Vizcaino, Tara G Bizjak, Tara R Gooen, Tawny L Colling, Teresa Jimenez, Thomas A Peter, Thomas J Arista, Tonia F Bernard, Tressa T Lewis, Valerie C Reed, Wei Wang, PhD, William D Tingley, William R Brubaker, William R Chang, Xiaoping Guan, Xiuju Lu, Yehualashet A Gessesse, Yung W Chan, Yvesna C Blaise, Zakaria I Ganiyu

Kinh Q Mac's Documents

Publish Date Document Type Title
April, 2011 FDA 483 EDDA Technology, Inc. - Form 483, 2011-04-11
August, 2002 FDA 483 Ethicon, Inc. - Form 483, 2002-08-08
September, 2010 FDA 483 Excelsior Medical Corporation - Form 483, 2010-09-24
August, 2002 FDA 483 BioSphere Medical S.A. - Form 483, 2002-08-29
October, 2009 FDA 483 Roche Molecular Systems, Inc. - Form 483, 2009-10-21
April, 2003 EIR Datascope Corp. - EIR, 2003-04-16
July, 2003 EIR Tissue Science Laboratories Limited - EIR, 2003-07-31
November, 2005 FDA 483 Roche Diagnostics Operations, Inc. - Form 483, 2005-11-04
April, 2002 FDA 483 Health Science Laboratories & Services Inc. - Form 483, 2002-04-30
November, 2001 EIR Howmedica Osteonics Corp - EIR, 2001-11-07
March, 2004 EIR Ethicon, Inc. - EIR, 2004-03-12
November, 2002 FDA 483 EBI, LLC - Form 483, 2002-11-07
August, 2010 FDA 483 Abbott Point Of Care Inc. - Form 483, 2010-08-11
August, 2002 EIR BioSphere Medical S.A. - EIR, 2002-08-29
February, 2005 FDA 483 Convatec Inc. - Form 483, 2005-02-08
May, 2001 FDA 483 Datascope Corp. - Form 483, 2001-05-30
May, 2005 FDA 483 Shelhigh, Inc. - Form 483, 2005-05-16
June, 2001 EIR Health Science Laboratories & Services Inc. - EIR, 2001-06-14
March, 2006 FDA 483 Therics LLC - Form 483, 2006-03-16
April, 2000 EIR Howmedica Osteonics Corp - EIR, 2000-04-13
February, 2002 FDA 483 Morelle Medical Products, Inc. - Form 483, 2002-02-01
March, 2005 FDA 483 Medtronic formerly Covidien - Form 483, 2005-03-03
February, 2006 EIR Ethicon, Inc. - EIR, 2006-02-09
April, 2003 FDA 483 Wien Laboratories, Inc. - Form 483, 2003-04-22
December, 2003 FDA 483 Cordis Corporation - Form 483, 2003-12-04
June, 2001 FDA 483 Health Science Laboratories & Services Inc. - Form 483, 2001-06-14
May, 2006 FDA 483 Biomet, Inc. - Form 483, 2006-05-23
March, 2005 EIR Medtronic formerly Covidien - EIR, 2005-03-03
July, 2007 EIR Cordis Corporation - EIR, 2007-07-26
May, 2010 FDA 483 Maquet Cardiovascular, LLC - Form 483, 2010-05-14
December, 2000 FDA 483 Response Shelhigh, Inc. - Form 483R, 2000-12-20
October, 2000 FDA 483 Fujifilm Medical Systems U.S.A., Inc. - Form 483, 2000-10-02
September, 2005 FDA 483 Response Ethicon, Inc. - Form 483R, 2006-03-14
May, 2003 FDA 483 Advanced Biomaterial Systems, Inc. - Form 483, 2003-05-08
August, 2004 EIR Faaborg Rehab Technic Aps - EIR, 2004-08-27
February, 2002 EIR Becton Dickinson & Company - EIR, 2002-02-20
July, 2003 FDA 483 Response Tissue Science Laboratories Limited - Form 483R, 2003-12-05
November, 2002 FDA 483 Vygon U.S.A. - Form 483, 2002-11-25
December, 2001 EIR Datascope Corp. - EIR, 2001-12-13
February, 2003 EIR Zimmer Gmbh - EIR, 2003-02-20
January, 2010 FDA 483 Excelsior Medical LLC - Form 483, 2010-01-08
August, 2002 EIR Ethicon, Inc. - EIR, 2002-08-08
December, 2000 FDA 483 Shelhigh, Inc. - Form 483, 2000-12-18
April, 2003 EIR Emerson Radio Corp - EIR, 2003-04-11
July, 2007 EIR Cordis Corporation - EIR, 2007-07-31
April, 2002 EIR Health Science Laboratories & Services Inc. - EIR, 2002-04-30
September, 2005 EIR Ethicon, Inc. - EIR, 2005-09-08
August, 2001 EIR FISHER SCIENTIFIC CHEMICAL DIVISION - EIR, 2001-08-22
April, 2004 FDA 483 Consumer Product Testing Company - Form 483, 2004-04-16
April, 2003 FDA 483 Emerson Radio Corp - Form 483, 2003-04-11
August, 2001 EIR Howmedica Osteonics Corp - EIR, 2001-08-30
May, 2000 EIR Diagnostica Stago, Inc. - EIR, 2000-05-17
November, 2001 FDA 483 Howmedica Osteonics Corp - Form 483, 2001-11-07
June, 2001 FDA 483 Response Health Science Laboratories & Services Inc. - Form 483R, 2001-06-24
August, 2001 FDA 483 Response FISHER SCIENTIFIC CHEMICAL DIVISION - Form 483R, 2001-09-14
August, 2001 FDA 483 FISHER SCIENTIFIC CHEMICAL DIVISION - Form 483, 2001-08-22
November, 2000 FDA 483 Howmedica Osteonics Corp - Form 483, 2000-11-15
April, 2009 FDA 483 Lingraphicare America, Inc. - Form 483, 2009-04-15
May, 2004 FDA 483 Terumo Cardiovascular Systems Corporation - Form 483, 2004-05-18
November, 2000 EIR Howmedica Osteonics Corp - EIR, 2000-11-15
July, 2002 EIR Thales Components Corporation - EIR, 2002-07-10
April, 2002 FDA 483 Response Health Science Laboratories & Services Inc. - Form 483R, 2002-05-10
April, 2004 EIR Consumer Product Testing Company - EIR, 2004-04-16
February, 2004 FDA 483 Medical Measurements, Inc. - Form 483, 2004-02-12
May, 2009 FDA 483 Zeus Scientific, Inc. - Form 483, 2009-05-27
December, 2003 FDA 483 Response Cordis Corporation - Form 483R, 2003-12-22
March, 2007 FDA 483 Roche Diagnostics Operations, Inc. - Form 483, 2007-03-09
April, 2010 FDA 483 Zargis Medical Corp. - Form 483, 2010-04-02
May, 2005 FDA 483 Response Shelhigh, Inc. - Form 483R, 2005-06-06
September, 2005 FDA 483 Ethicon, Inc. - Form 483, 2005-09-08
July, 2010 FDA 483 Convatec Inc. - Form 483, 2010-07-01
August, 2004 FDA 483 Faaborg Rehab Technic Aps - Form 483, 2004-08-27
April, 2004 FDA 483 Response Consumer Product Testing Company - Form 483R, 2004-04-16
April, 2003 FDA 483 Response Wien Laboratories, Inc. - Form 483R, 2003-05-07
November, 2010 FDA 483 Circassia Pharmaceuticals Inc - Form 483, 2010-11-05
July, 2003 EIR Boston Scientific Limited - EIR, 2003-07-24
September, 2002 FDA 483 Nobel Biocare AB (dba -Nobel Biocare Production) - Form 483, 2002-09-06
August, 2010 EIR Abbott Point Of Care Inc. - EIR, 2010-08-11
February, 2006 FDA 483 Response Ethicon, Inc. - Form 483R, 2006-02-24
April, 2002 EIR EBI, LLC - EIR, 2002-04-10
February, 2006 FDA 483 Ethicon, Inc. - Form 483, 2006-02-09
March, 2010 FDA 483 Artegraft, Inc. - Form 483, 2010-03-08
February, 2002 FDA 483 Response Becton Dickinson & Company - Form 483R, 2002-03-08
February, 2002 FDA 483 Becton Dickinson & Company - Form 483, 2002-02-20
February, 2003 FDA 483 Zimmer Gmbh - Form 483, 2003-02-20
April, 2000 FDA 483 Howmedica Osteonics Corp - Form 483, 2000-04-13
November, 2001 EIR Howmedica Osteonics Corp - EIR, 2001-11-07
February, 2004 FDA 483 Response Medical Measurements, Inc. - Form 483R, 2004-02-23
August, 2002 FDA 483 Response BioSphere Medical S.A. - Form 483R, 2002-09-17
May, 2010 FDA 483 Response Maquet Cardiovascular, LLC - Form 483R, 2010-05-14
November, 2001 FDA 483 Howmedica Osteonics Corp - Form 483, 2001-11-07
April, 2002 FDA 483 EBI, LLC - Form 483, 2002-04-10
October, 2001 FDA 483 Genzyme Corporation - Form 483, 2001-10-02
July, 2003 FDA 483 Tissue Science Laboratories Limited - Form 483, 2003-07-31
May, 2001 FDA 483 Response Datascope Corp. - Form 483R, 2001-06-06
April, 2009 FDA 483 Medical Accessories, Inc. - Form 483, 2009-04-30
April, 2003 EIR Wien Laboratories, Inc. - EIR, 2003-04-22
September, 2002 FDA 483 Nobel Biocare - Form 483, 2002-09-06
December, 2010 FDA 483 Artegraft, Inc. - Form 483, 2010-12-20
March, 2008 FDA 483 Berkeley Contract Packaging, Llc - Form 483, 2008-03-04
May, 2003 EIR Advanced Biomaterial Systems, Inc. - EIR, 2003-05-08
December, 2000 EIR Shelhigh, Inc. - EIR, 2000-12-18
May, 2001 EIR Datascope Corp. - EIR, 2001-05-30

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