St. Jude Medical – FDA Inspection, Jul 28, 2016

Record Details

This FDA Inspection record concerns St. Jude Medical, with an inspection on July 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: St. Jude Medical
Inspection Date: July 28, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 198b4cac-8ece-4b4b-ab9f-1a8e423b2b4e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 980509
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.100(b)Documentation
21 CFR 820.40(a)Document review, approval by designated individual
21 CFR 820.70(g)(2)Periodic equipment inspections
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.70(a)Production processes
21 CFR 820.90(a)Nonconforming product control
21 CFR 820.40(b)Document change records, maintained.

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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
June 26, 2015	OAI	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