Baxter Healthcare Corporation – FDA Inspection, Aug 28, 2012

Record Details

This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on August 28, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Baxter Healthcare Corporation
Inspection Date: August 28, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · e3abb02f-b7c2-450b-b8cd-806f4bfd40be

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 797090
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

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Other FDA inspections of Baxter Healthcare Corporation

Date	Classification	Office	Project area
April 4, 2025	NAI	New York District Office	Postmarket Assurance: Medical Devices
September 28, 2021	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 21, 2017	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
December 8, 2010	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 31, 2010	VAI	Center for Devices and Radiological Health	Compliance: Devices