St. Jude Medical – FDA Inspection, Jun 26, 2015

Record Details

This FDA Inspection record concerns St. Jude Medical, with an inspection on June 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: St. Jude Medical
Inspection Date: June 26, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · c8d4e005-333b-4cf8-a93c-d0ffe3bd209a

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 932468
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(b)Incoming acceptance records, documentation
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.100(b)Documentation
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.70(g)Equipment design and installation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.70(a)Production processes
21 CFR 820.22Quality audit - audit report review
21 CFR 820.30(j)Design history file

Showing 10 of 11 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of St. Jude Medical

Date	Classification	Office	Project area
August 13, 2024	NAI	Center for Devices and Radiological Health	Compliance: Devices
March 20, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices
July 28, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices
November 30, 2011	OAI	Center for Devices and Radiological Health	Bioresearch Monitoring
June 15, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices