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•United States

Medtronic MiniMed, Inc., Northridge, CA – FDA Inspections

Inspection records and compliance data for Medtronic MiniMed, Inc. in Northridge, California. 14 FDA inspections on record (2 OAI), 3 Form 483s, last inspected January 03, 2024.

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Company Profile

This profile covers Medtronic MiniMed, Inc. based in Northridge, California, United States.

FDA Inspection History

FDA inspections
14
OAI
2
VAI
4
NAI
8
Form 483s
3
Warning letters
0

First inspected September 8, 2010. Last inspected January 3, 2024.

Most cited issue areas

  • Investigation of device failures2 inspections
  • Lack of or inadequate procedures2 inspections
  • Sponsor device disposition records inadequate2 inspections

FDA inspections (14)

DateResultFDA center(s)Insp. #
January 3, 2024NAIMedical Devices & Rad Health · Bioresearch Monitoring1226943
March 10, 2023NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1199488
July 7, 2021OAIMedical Devices & Rad Health · Compliance: Devices1145642
February 15, 2019NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1082648
March 14, 2018VAIMedical Devices & Rad Health · Project Evaluation: Devices1044249
August 14, 2017NAIMedical Devices & Rad Health · Compliance: Devices1022946
March 24, 2017NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1005666
July 22, 2016VAIMedical Devices & Rad Health · Bioresearch Monitoring981630
July 22, 2016VAIMedical Devices & Rad Health · Bioresearch Monitoring979214
November 21, 2014NAIMedical Devices & Rad Health · Bioresearch Monitoring907242
December 16, 2013VAIMedical Devices & Rad Health · Bioresearch Monitoring859043
April 12, 2013OAIMedical Devices & Rad Health · Compliance: Devices821664
February 9, 2011NAIMedical Devices & Rad Health · Compliance: Devices711067
September 8, 2010NAIMedical Devices & Rad Health · Compliance: Devices679427
FDA documents

Form 483s (4)

  • Form 483s · March 10, 2023
  • Form 483s · July 7, 2021
  • Form 483s · March 14, 2018
  • Form 483s · July 22, 2016

EIRs (6)

  • EIRs · March 10, 2023
  • EIRs · February 15, 2019
  • EIRs · March 14, 2018
  • EIRs · August 14, 2017
  • EIRs · March 24, 2017
  • EIRs · July 22, 2016
People (5)
Sarah A. Hassas
Person
Elizabeth A. Dakan
Person
Stephen R. Souza
Person
Norma Ojeda
Person
Andrea Bell-Vlasov
Person
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Company Information

Name

Medtronic MiniMed, Inc.

FEI Number

3003166194

Address

18000 Devonshire St, Northridge, California 91325, United States

Country

United States

ID: a75f6a75-6d10-41f1-8c92-839535f005bf

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