FDA Investigator Mary R Hole

Mary R Hole has inspections in 3 countries as of 20 Sep 2023. Mary R Hole has collaborated with a combinined 2046 experts on various inspections, contributing to compliance and improvement across diverse sectors.

Investigator Details

Number of Inspected Sites:
91
Last Inspection Date:
20 Sep 2023
Investigator Role:
FDA Investigator
Redica ID:
100002755
Country:
United States of America, China
Co-Investigator(s):
A Williams, Acton, Adam S Freeman, Alice A Blair, Alison A Nicoli, Alla Dubrovsky, Amogh Pathi, Andrea P Scott, Andrew K Haack, PhD, Angela D Wise, Anna L Marroquin, Ashley A Mutawakkil, Bak, 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 L Ford, Daniel C Geffin, Daniel J Roberts, Daniel Velasquez, Darin S Wiegers, Dena L Jacobs, Dr. Monica D Cooper, Eileen M Malecki, Elizabeth A Dakan, Elodie Xtong 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, Harperd, 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, Joseph Tibay, Juan A Morales, Juanj Wu, Jude C Dikes, Kacie M Crowther, Karen D Phung, Katie T Duong, Kavita K Lalwani, Kenya Destin, Kimberly L Anderson, Kimberly L Pruszko, Lance A Finnical, Laverne Puckett, Lawton W Lum, Lee, Leongc, Linda Linh T Nguyen, Linda Linhn Adams, Linda S Shook, Lori J Silverstein, Lorraine N Williams, LT Mark A Chen, MPH, Lucila B Nwatu, Lydia S Chan, Maida Henesian (NMI), Mark E Chan, Matthew D Schnittker, Matthew M Vernon, Max Lager, Mcgrewp, Monique C Lo, 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, State Agency, 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
January, 2013 FDA 483 Xlumena, Inc. - Form 483, 2013-01-16
August, 2016 EIR Miramar Labs, Inc. - EIR, 2016-08-01
October, 2014 FDA 483 Hansen Medical Inc - Form 483, 2014-10-16
September, 2015 FDA 483 Theranos, Inc. - Form 483, 2015-09-16
July, 2015 FDA 483 Affymetrix, Inc. - Form 483, 2015-07-29
August, 2014 FDA 483 Suni Medical Imaging - Form 483, 2014-08-21
December, 2013 FDA 483 Flextronics America LLC - Form 483, 2013-12-27
April, 2015 FDA 483 The Medicines Company - Form 483, 2015-04-17
August, 2014 FDA 483 AccessClosure, Inc., A Cardinal Health Company - Form 483, 2014-08-05
August, 2015 FDA 483 Sciton Inc. - Form 483, 2015-08-20
July, 2016 FDA 483 Helio USA Inc - Form 483, 2016-07-06
January, 2016 EIR Heron Therapeutics, Inc. - EIR, 2016-01-06
May, 2015 FDA 483 Helio USA Inc - Form 483, 2015-05-12
February, 2015 FDA 483 Dm Systems Beijing Co Ltd - Form 483, 2015-02-10
July, 2013 FDA 483 Topcon Medical Laser Systems, Inc. - Form 483, 2013-07-10
March, 2012 FDA 483 Chestnut Medical Technologies Inc. - Form 483, 2012-03-29
November, 2013 FDA 483 Prime Herbs Corporation - Form 483, 2013-11-06
December, 2011 FDA 483 Siemens Medical Solutions USA, Inc. - Form 483, 2011-12-19
September, 2016 FDA 483 Covidien, LLC - Form 483, 2016-09-20
May, 2012 FDA 483 Rapid Diagnostics, Division Of Mp Biomedicals, Llc - Form 483, 2012-05-14
November, 2014 FDA 483 Concentric Medical Inc - Form 483, 2014-11-10
December, 2014 FDA 483 Sgarlato Med, LLC - Form 483, 2014-12-19
March, 2013 FDA 483 Neuropace Inc - Form 483, 2013-03-05
August, 2015 FDA 483 Response Sciton Inc. - Form 483R, 2015-09-11
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
August, 2014 FDA 483 AccessClosure, Inc. - Form 483, 2014-08-05
August, 2013 FDA 483 Lumasense Technologies, Inc. - Form 483, 2013-08-28
December, 2012 FDA 483 Intersect ENT, INC. - Form 483, 2012-12-11
October, 2015 EIR Intuitive Surgical, Inc. - EIR, 2015-10-14
November, 2010 FDA 483 Hologic, Inc. - Form 483, 2010-11-17
June, 2016 EIR Transcend Medical Inc. - EIR, 2016-06-15
August, 2015 EIR Sciton Inc. - EIR, 2015-08-20
March, 2014 FDA 483 Intuitive Surgical, Inc. - Form 483, 2014-03-21
June, 2015 FDA 483 Becton, Dickinson and Company, BD Biosciences - Form 483, 2015-06-19
December, 2013 FDA 483 Phoenix Deventures - Form 483, 2013-12-06
April, 2014 FDA 483 Nidek, Inc. - Form 483, 2014-04-14
September, 2015 EIR Theranos, Inc. - EIR, 2015-09-16
March, 2017 FDA 483 UCP Bioscience Inc - Form 483, 2017-03-17
November, 2012 FDA 483 Sheathing Technologies Inc - Form 483, 2012-11-23
August, 2012 FDA 483 ZOLL Circulation, Inc. - Form 483, 2012-08-15
August, 2016 FDA 483 Miramar Labs, Inc. - Form 483, 2016-08-01
May, 2013 FDA 483 Intuitive Surgical, Inc. - Form 483, 2013-05-30
July, 2012 FDA 483 U-systems Inc - Form 483, 2012-07-13
July, 2014 FDA 483 Anatomage, Inc. - Form 483, 2014-07-07

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