FDA Investigator Maura Rooney

Maura Rooney has conducted inspections on 65 sites in 4 countries as of 07 Jul 2021. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
65
Last Inspection Date:
07 Jul 2021
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
China, United States of America, Korea (Republic of), Japan
FDA Investigators that have inspected at least one site in common with Maura Rooney:
Abby E Pelletier, Alan M Stevens, Alan R Condon, Allison A Rodriguez, Althea A Williams, Amber G Wardwell, Andrew M Barlow, Arie C Menachem, Ashley M Whitehurst, Barbara G Swan, Brenda P King, Camerson E Moore, Carla C Cummins, Carla C Tuite, Constance Desimone, Cynthia L Gorveatt, Darin S Wiegers, David J Feria, David P Vanhouten, Dawn M Braswell, Diane C Thibodeau, Diane M Biron, Dien N Nguyen, Dolores Harper, Dorothy W Lee, Dr. Gang Wang, PhD, Edward J Janik, Elizabeth B Griffin, Ellen P Madigan, Eric C Schmitt, Frank P Hurst, Garry H Stewart, Gary J Hagan, George T Allen, Jr, Jacqueline Mdiaz Albertini, Jacqueline S Warner, James H Tanner, James P Finn, James W Whitney, Janete F Guardia, Jason A Rossi, Jayaleka J Amarasinghe, Jeffrey J Thibodeau, John A Sciacchitano, John P Mistler, Jonathan B Lewis, Jonathan G Matrisciano, Juanita Banuelos, Justine M Corson, Karen Mcnabb Noon, Katarzyna Plona, Kathleen M Curry, Kayla R Huffman, Kent A Conforti, Kristina J Donohue, Lauren M Lawrance, Lauren M Mclaughlin, Laurie B Frazier, LCDR Debra Emerson, Leonard H Lavi, Linda A Gregory Duty, Lori J Silverstein, Lori M Newman, Lori S Lawless, Lynne M Dwyer, Marcia M Laughrey, Margaret M Doherty, Margaret M Sands, Mark R Mcclain, Mary Jeanet Mcgarry, Maryam Tabatabaie, Matthew B Hazelett, Maya M Davis, Megan A Haggerty, Michael G Mayfield, Michael P Anthony, Michael P Sweeney, Michael Serrano, Mutahar S Shamsi, Nabil Nakhoul, Pamela N Agaba, Paul E Stein, Paul M Kawamoto, Paul P Geraci, Perry H Gambrell, Philip H Lafleur, Preston M Lee, Qiao Y Bobo, Ramon E Martinez, Rebecca B Welch, Ronald A Stokes, Rory K Geyer, Ryan J Mcgowan, Sandra P White, Sara M Onyango, Scott B Laufenberg, Seth A Mailhot, Shawn M Bogdan, Sherry M Nisson, Stacey S Degarmo, Stephen C King, Stephen C Smith, Stephen D Eich, Stephen R Souza, Steven M Ferrara, Sunita Pandey, Susanne M Richardson, MS RAC, Suzanne M Healy, Tamara S Rosbury, Tanya R Syffrard, Terry C Kimball, Todd J Maushart, Tomika L Crafter, Xiaojun Yan

Maura Rooney's Documents

Publish Date Document Type Title
October, 2013 FDA 483 Atrium Medical Corporation - Form 483, 2013-10-01
March, 2013 FDA 483 Hemedex, Inc. - Form 483, 2013-03-14
March, 2020 FDA 483 Concert Medical, LLC - Form 483, 2020-03-05
April, 2011 FDA 483 Belmont Instrument Corporation - Form 483, 2011-04-27
July, 2021 EIR CooperSurgical, Inc. - EIR, 2021-08-12
July, 2021 FDA 483 CooperSurgical, Inc. - Form 483, 2021-07-15
March, 2013 FDA 483 Hightech American Industrial Laboratories, Inc. - Form 483, 2013-03-22
February, 2013 FDA 483 Fresenius Medical Care Holdings, Inc. - Form 483, 2013-02-21
October, 2012 FDA 483 The Judge Rotenberg Educational Center, Inc. - Form 483, 2012-10-17
January, 2012 FDA 483 Nova Biomedical Corporation - Form 483, 2012-01-13
November, 2011 FDA 483 Fresenius Medical Care Holdings, Inc. - Form 483, 2011-10-28
September, 2010 FDA 483 Carrot Medical, LLC - Form 483, 2010-09-29
December, 2011 FDA 483 Insulet Corporation - Form 483, 2011-12-19
November, 2012 FDA 483 Anika Therapeutics Inc - Form 483, 2012-11-14
July, 2011 FDA 483 Medical Information Technology, Inc. - Form 483, 2011-07-08
April, 2012 FDA 483 Cynosure, Inc. - Form 483, 2012-04-25
May, 2012 FDA 483 YANG MING INDUSTRY (ZHEJIANG) LIMITED - Form 483, 2012-05-24
December, 2009 FDA 483 Anika Therapeutics, Incorporated - Form 483, 2009-12-16
March, 2012 FDA 483 Abbott Laboratories - Form 483, 2012-03-16
April, 2012 FDA 483 Direx Systems Corp. - Form 483, 2012-04-04
May, 2013 FDA 483 Dongguan Mars Medical Products Co., Ltd. - Form 483, 2013-05-30
September, 2012 FDA 483 Brain Research, Inc. - Form 483, 2012-09-07
December, 2012 FDA 483 Primo Medical Group, Inc - Form 483, 2012-12-10
April, 2013 FDA 483 Draeger Medical Systems, Inc. - Form 483, 2013-04-12

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