Maura Rooney - FDA Investigator Report

Designation: SUPERVISORY CONSUMER SAFETY

Duty Station: Stoneham MA 02180

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO DMDRHOI MDRHIB

Overview Statistics

65
Total Inspections
40
Total 483s Issued
2
Warning Letters Issued

Inspection Details

Longest Inspection: 85 days
Shortest Inspection: 1 days
Average Length: 2.7 days

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Maura Rooney's Recent Inspections

DateCompanyCityCountryFEI Number483
2021-07-15CooperSurgical, Inc.TrumbullUnited States1216677
2020-03-05Concert Medical, LLCNorwellUnited States1000137702
2016-04-08Boston Scientific CorporationQuincyUnited States3001451463
2013-10-01Atrium Medical CorporationHudsonUnited States1219977
2013-05-30Dongguan Mars Medical Products Co., Ltd.Dani Village, Shatian Town, DongguanChina3003171455
2013-05-23Megagen Implant Co., Ltd.Gyeongsan-siKorea (the Republic of)3005554774
2013-05-15Nipro Medical Industries, Ltd.TatebayashiJapan3002807725
2013-04-12Draeger Medical Systems, Inc.AndoverUnited States3005783425
2013-03-22Hightech American Industrial Laboratories, Inc.LexingtonUnited States3003046678
2013-03-14Hemedex, Inc.WalthamUnited States3003730855

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Maura Rooney - Co-Inspectors

NameInspectionsLast Inspection
John A Sciacchitano32012
Stephen C Smith22021
Lauren M Lawrance22012
Susanne M Richardson22012
Elizabeth B Griffin22012
Allison A Rodriguez22010
Abby E Pelletier22010
Michael P Sweeney22009
Preston M Lee12020
James P Finn12016
Jonathan G Matrisciano12011
Justine M Corson12011
James W Whitney12010
Brenda P King12009
Ashley M Whitehurst12009
Suzanne M Healy12009

Maura Rooney's Active Locations

  • United States
  • China
  • Japan
  • Korea (the Republic of)

Maura Rooney's Year-wise Inspection Count

  • 2009:13 inspections
  • 2010:14 inspections
  • 2011:12 inspections
  • 2012:15 inspections
  • 2013:8 inspections
  • 2016:1 inspections
  • 2020:1 inspections
  • 2021:1 inspections
Last Updated: 2025-05-14 06:11:22