FDA Investigator: Maura Rooney
- Maura Rooney first started conducting FDA inspections in 2009, with the last inspection in 2021. Over that time, Maura Rooney has conducted 63 inspections at 60 companies across 61 sites.
Get Maura Rooney's official FDA inspection documents. Gain valuable insights from their Form 483s and EIRs to ace your next inspection.
Documents
Upon purchase, you will receive an email with a link to immediately download the documents.
FDA 483 CooperSurgical, Trumbull | July 2021
Available Now - $199
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Concert Medical, LLC, Norwell | 2020
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Atrium Medical Corporation, Hudson | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Dongguan Mars Medical Products Co., Ltd., Dani Village, Shatian Town, Dongguan | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Megagen Implant Co., Ltd., Gyeongsan-si | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Megagen Implant Co., Ltd., Gyeongsan-si | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Draegar Medical Systems, Inc., Andover | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Hai Laboratories Inc., Lexington | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Hemedex, Incorporated, Cambridge | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Fresenius Medical Care Holdings, Inc., Waltham | 2013
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Cardiosolutions, West Bridgewater | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Anika Therapeutics, Incorporated, Bedford | 2012
Out-of-stock
Maura Rooney
Animal Drugs & Feed Form 483
FDA 483 The Judge Rotenberg Educational Center, Inc., Canton | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Brain Research, Inc., Boston | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Sekisui Diagnostics LLC, Framingham | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Medical & Biological Laboratories Co., Ltd./INA Lab, Ina-shi | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 YANG MING INDUSTRY (ZHEJIANG) LIMITED, PINGHU | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Cynosure, Inc., Westford | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Direx Systems Corp., Canton | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Thoratec Corporation, Burlington | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Pointcare Technologies, Inc., Marlborough | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Nova Biomedical Corporation, Waltham | 2012
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Insulet Corporation, Bedford | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Fresenius Medical Care Holdings, Inc., Waltham | 2011
Out-of-stock
Maura Rooney
Human Drug Form 483
FDA 483 MBL International Corporation, Woburn | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Medical Information Technology, Inc., Westwood | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Grass Technologies, Natus Medical Inc., Rockland | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Belmont Instrument Corporation, Billerica | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Boston Foundation For Sight, Needham | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Std Med, Inc., Stoughton | 2011
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Philips Medical Systems, Inc., Andover | 2010
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
FDA 483 Carrot Medical, LLC, Bothell | 2010
Out-of-stock
Maura Rooney
Medical Devices & Rad Health Form 483
Co-Investigators (16)
- Stephen C. Smith, FDA Investigator
- Preston M. Lee, FDA Investigator
- James P. Finn, FDA Investigator
- Lauren M. Lawrance, FDA Investigator
- John A. Sciacchitano, FDA Investigator
- Elizabeth B. Griffin, FDA Investigator
- Susanne M. Richardson, FDA Investigator
- Justine M. Corson, FDA Consumer Safety Officer
- Jonathan G. Matrisciano, FDA Investigator
- James W. Whitney, FDA Investigator
- Abby E. Pelletier, FDA Investigator
- Allison A. Rodriguez, FDA Investigator
- Brenda P. King, FDA Investigator
- Suzanne M. Healy, FDA Investigator
- Ashley M. Whitehurst, FDA Investigator
- Michael P. Sweeney, FDA Investigator

