FDA Investigator

Maura Rooney

Latest inspection on record: Trumbull, United States, July 2021 · records back to 2009

Medical Devices & Rad Health

FDA inspection record · Last updated July 12, 2026

Overview

  • 65 inspections across 64 sites are on record.
  • 138 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2021-07-15.

At a glance

Inspections

65

Sites

64

Observations

138

Career since

May 2009

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
CooperSurgical, Inc.15 Jul 2021Medical Devices & Rad HealthOn file
Concert Medical, LLC5 Mar 2020Medical Devices & Rad HealthOn file
Boston Scientific Corporation8 Apr 2016Medical Devices & Rad Health
Atrium Medical Corporation1 Oct 2013Medical Devices & Rad HealthOn file
Dongguan Mars Medical Products Co., Ltd.30 May 2013Medical Devices & Rad HealthOn file

Sites inspected

CooperSurgical, Inc.Trumbull, United States1 insp.
Concert Medical, LLCNorwell, United States1 insp.
Boston Scientific CorporationQuincy, United States1 insp.
Atrium Medical CorporationHudson, United States1 insp.
Dongguan Mars Medical Products Co., Ltd.Dani Village, Shatian Town, Dongguan, China1 insp.

Co-investigators

Investigators who share inspections with this person.

Stephen C Smith2 shared
Lauren M Lawrance2 shared
Susanne M Richardson2 shared
Elizabeth B Griffin2 shared
Allison A Rodriguez2 shared
Abby E Pelletier2 shared
Michael P Sweeney2 shared
James P Finn1 shared

Full investigator report

Get the verbatim findings behind Maura Rooney's 138 observations

Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.

  • New inspections and Form 483s, mapped to the CFR citation
  • Warning letter outcomes, and the citation patterns they repeat
  • Their co-investigators, so no surprises about who shows up on site

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