FDA Investigator Mary R Hole

Mary R Hole has conducted inspections on 91 sites in 2 countries as of 24 Oct 2022. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
91
Last Inspection Date:
24 Oct 2022
Investigator Role:
FDA Investigator
Redica ID:
100002755
Countries of Inspections:
United States of America, China
FDA Investigators that have inspected at least one site in common with Mary R Hole:
Adam S Freeman, Alice A Blair, Alison A Nicoli, Alla Dubrovsky, Althea A Williams, Amogh Pathi, Andrea P Scott, Andrew K Haack, PhD, Angela D Wise, Anna L Marroquin, Ashley A Mutawakkil, Breena L D'ambrogi, Brian R Henderson, Brittany D Mccracken, Bryan S Roddy, Carl Lee, Carol A Llewellyn, CDR Rochelle B Young, RPh, MSA, Celeste K Wong, Chengjiu Hu, Chloe Anne Leong, Christine I Shaw, Christine M Parmentier, Christopher W Buser, Cindy W Lewis, Cynthia J Tsui, Cynthia L Ford, Daniel C Geffin, Daniel J Roberts, Daniel Velasquez, Darin S Wiegers, Dena L Jacobs, Dolores Harper, Dr. Monica D Cooper, Dustin R Abaonza, Eileen M Malecki, Elizabeth A Dakan, Elodie X Tong Lin, Emmanuel A Dimaano, Jr, Eric C Nielsen, Eric J Heinze, Eric W Anderson, Francis J Eng, Frank P Bianco, Gary L Zaharek, George R Richards, Gillenwater, Glen E Harelson, Gulshan R Anand, Humberto Z Gomez, Jacqueline M Cleary, James A Lane, Jeffrey S Buckser, Jeffrey W Shrifter, DPM, Jennifer L Johnson, Jocelyn T Ramos, John Cheung, Jolene S Hedgecock, Joseph A Seitz, III, Joseph Tibay, Juan A Morales, Juanj N Wu, Jude C Dikes, Kacie M Crowther, Karen D Phung, Katie T Duong, Kavita K Lalwani, Kenya Destin, Kimberly L Anderson, Kimberly L Pruszko, Kristin M Abaonza, Lance A Finnical, Laverne Puckett, Lawton W Lum, Linda Linh N Adams, Linda S Shook, Linh Tu, Lori J Silverstein, Lorraine N Williams, LT Mark A Chen, MPH, Lucila B Nwatu, Lydia S Chan, Maida Henesian (NMI), Mark E Chan, Mary C Acton, Matthew D Schnittker, Matthew M Vernon, Max Lager, Mcgrewp, Monique C Lo, Nga T Ho, Paul M Kawamoto, Phillip M Pontikos, Quynh H Strandberg, Randall F Albright, Randall J Plunkett, Raymond Souweha, Raymond T Oji, Rebecca T Davis, Roberta K Smith, Ronald P Boyce, Sandra S Saniga, Seema S Singh, Sergio Chavez (NMI), Sherri N Rohlf, MD, Stanley B Eugene, BS, BME, Stayce E Beck, Stephanie A Slater, MS, Stephen R Souza, Stuart W Russell, Suzie L Kent, Thea C Grome, Thomas N Adjabeng, Timothy C Grome, Uduak M Inokon, Vi T Au, Walden H Lee, William J Weis, William V Millar, Xiaojun Yan, Yung W Chan, Yvonne C Wilkes

Mary R Hole's Documents

Publish Date Document Type Title
December, 2013 FDA 483 Phoenix Deventures - Form 483, 2013-12-06
July, 2012 FDA 483 U-systems Inc - Form 483, 2012-07-13
November, 2014 FDA 483 Concentric Medical Inc - Form 483, 2014-11-10
August, 2015 EIR Sciton Inc. - EIR, 2015-08-20
March, 2013 FDA 483 Neuropace Inc - Form 483, 2013-03-05
June, 2016 EIR Transcend Medical Inc. - EIR, 2016-06-15
July, 2015 FDA 483 Affymetrix, Inc. - Form 483, 2015-07-29
May, 2015 FDA 483 Helio USA Inc - Form 483, 2015-05-12
August, 2015 FDA 483 Response Sciton Inc. - Form 483R, 2015-09-11
March, 2012 FDA 483 Chestnut Medical Technologies Inc. - Form 483, 2012-03-29
August, 2016 EIR Miramar Labs, Inc. - EIR, 2016-08-01
November, 2013 FDA 483 Prime Herbs Corporation - Form 483, 2013-11-06
December, 2014 FDA 483 Sgarlato Med, LLC - Form 483, 2014-12-19
September, 2016 FDA 483 Covidien, LLC - Form 483, 2016-09-20
December, 2012 FDA 483 Intersect ENT, INC. - Form 483, 2012-12-11
April, 2014 FDA 483 Nidek, Inc. - Form 483, 2014-04-14
July, 2013 FDA 483 Topcon Medical Laser Systems, Inc. - Form 483, 2013-07-10
July, 2014 FDA 483 Anatomage, Inc. - Form 483, 2014-07-07
December, 2011 FDA 483 Siemens Medical Solutions USA, Inc. - Form 483, 2011-12-19
September, 2015 EIR Theranos, Inc. - EIR, 2015-10-30
June, 2015 FDA 483 Becton, Dickinson and Company, BD Biosciences - Form 483, 2015-06-19
October, 2015 EIR Intuitive Surgical, Inc. - EIR, 2015-10-14
November, 2012 FDA 483 Sheathing Technologies Inc - Form 483, 2012-11-23
August, 2014 FDA 483 AccessClosure, Inc. - Form 483, 2014-08-05
October, 2014 FDA 483 Hansen Medical Inc - Form 483, 2014-10-16
May, 2012 FDA 483 Rapid Diagnostics, Division Of Mp Biomedicals, Llc - Form 483, 2012-05-14
August, 2014 FDA 483 AccessClosure, Inc., A Cardinal Health Company - Form 483, 2014-08-05
April, 2015 FDA 483 The Medicines Company - Form 483, 2015-04-17
August, 2013 FDA 483 Lumasense Technologies, Inc. - Form 483, 2013-08-28
January, 2013 FDA 483 Xlumena, Inc. - Form 483, 2013-01-16
August, 2014 FDA 483 Suni Medical Imaging - Form 483, 2014-08-21
August, 2016 FDA 483 Miramar Labs, Inc. - Form 483, 2016-08-01
November, 2010 FDA 483 Hologic, Inc. - Form 483, 2010-11-17
February, 2015 FDA 483 Dm Systems Beijing Co Ltd - Form 483, 2015-02-10
May, 2013 FDA 483 Intuitive Surgical, Inc. - Form 483, 2013-05-30
December, 2013 FDA 483 Flextronics America LLC - Form 483, 2013-12-27
August, 2012 FDA 483 ZOLL Circulation, Inc. - Form 483, 2012-08-15
August, 2015 FDA 483 Sciton Inc. - Form 483, 2015-08-20
September, 2015 FDA 483 Theranos, Inc. - Form 483, 2015-09-16
March, 2015 FDA 483 Siemens Medical Solutions USA, Inc. - Form 483, 2015-03-27
June, 2012 FDA 483 ZOLL Circulation, Inc. - Form 483, 2012-06-21
July, 2016 FDA 483 Helio USA Inc - Form 483, 2016-07-06
March, 2014 FDA 483 Intuitive Surgical, Inc. - Form 483, 2014-03-21
January, 2016 EIR Heron Therapeutics, Inc. - EIR, 2016-01-06
March, 2017 FDA 483 UCP Bioscience Inc - Form 483, 2017-03-17

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