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FDA Inspection
•Medtronic MiniMed, Inc.•March 24, 2017

Medtronic MiniMed, Inc. – FDA Inspection, Mar 24, 2017

Record Details

This FDA Inspection record concerns Medtronic MiniMed, Inc., with an inspection on March 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Medtronic MiniMed, Inc.
Inspection Date
March 24, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Janet Pulver (FDA Associated Person)
View Company Profile

ID · fa6d117d-ca0a-4b8c-af3e-742354fb7592

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1005666
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 820.150Lack of or inadequate procedures for storage.
  2. 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
  3. 21 CFR 820.90(a)Nonconforming product control

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Medtronic MiniMed, Inc.

13
DateClassificationOfficeProject area
January 3, 2024NAICenter for Devices and Radiological HealthBioresearch Monitoring
March 10, 2023NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
July 7, 2021OAICenter for Devices and Radiological HealthCompliance: Devices
February 15, 2019NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
March 14, 2018VAICenter for Devices and Radiological HealthProject Evaluation: Devices
View all 13 other inspections on the company page
Other documents for Medtronic MiniMed, Inc.
  • FDA Inspection 1226943 - 2024-01-03
  • FDA Inspection 1199488 - 2023-03-10
  • FDA Inspection 1145642 - 2021-07-07
  • FDA Inspection 1082648 - 2019-02-15
  • FDA Inspection 1044249 - 2018-03-14

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