Medtronic Inc. – FDA Inspection, Aug 6, 2009

Record Details

This FDA Inspection record concerns Medtronic Inc., with an inspection on August 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Medtronic Inc.
Inspection Date: August 6, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 747fd091-d298-491e-ab24-e85c09a16691

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 606896
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.100(a)(2)Investigation procedures
21 CFR 820.100(b)Procedures

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Other FDA inspections of Medtronic Inc.

Date	Classification	Office	Project area
February 10, 2025	VAI	Minneapolis District Office	Compliance: Medical Devices
September 1, 2023	NAI	Center for Devices and Radiological Health	Bioresearch Monitoring
February 4, 2020	VAI	Center for Devices and Radiological Health	Bioresearch Monitoring
August 16, 2018	Not classified	Minneapolis District Office
May 14, 2018	OAI	Center for Devices and Radiological Health	Compliance: Devices