Ethicon, Inc. – FDA Inspection, Sep 14, 2017

Record Details

This FDA Inspection record concerns Ethicon, Inc., with an inspection on September 14, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: Ethicon, Inc.
Inspection Date: September 14, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Claudette D. Brooks (FDA Associated Person)

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ID · 196d5a1d-e8d7-4de3-b893-33f427bcad2f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1025149
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.75(c)Process changes - review, evaluation and revalidation
21 CFR 820.100(b)Documentation
21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
21 CFR 820.70(a)Production processes
21 CFR 820.90(a)Nonconforming product control
21 CFR 820.20(c)Management review dates

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Other FDA inspections of Ethicon, Inc.

Date	Classification	Office	Project area
September 27, 2018	Not classified	Atlanta District Office
May 12, 2017	Not classified	Atlanta District Office
April 24, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 30, 2013	VAI	Center for Devices and Radiological Health	Compliance: Devices
February 27, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices