Zimmer, Inc. – FDA Inspection, Jul 22, 2011

Record Details

This FDA Inspection record concerns Zimmer, Inc., with an inspection on July 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Zimmer, Inc.
Inspection Date: July 22, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · da0ed67a-d781-4c3a-930c-7b5c18b4d1ac

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 737965
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.72(a)Equipment suitability & capability
21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.20(a)Management ensuring quality policy is understood
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(c)Design input - Lack of or inadequate procedures
21 CFR 820.30(d)Design output - Lack of or inadequate procedures
21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
21 CFR 820.184DHR content

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Other FDA inspections of Zimmer, Inc.

Date	Classification	Office	Project area
February 9, 2026	Not classified	Detroit District Office
July 27, 2022	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
October 16, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
November 20, 2015	OAI	Center for Devices and Radiological Health	Compliance: Devices
May 28, 2014	OAI	Center for Devices and Radiological Health	Compliance: Devices