Baxter Healthcare Corporation – FDA Inspection, Jun 7, 2012

Record Details

This FDA Inspection record concerns Baxter Healthcare Corporation, with an inspection on June 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Baxter Healthcare Corporation
Inspection Date: June 7, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a26fb1ee-d16a-4501-8993-bef7124b56dc

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 784215
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 211.94(a)Reactive/Additive/Absorptive Containers/Closures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(c)Design input - Lack of or inadequate procedures
21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
21 CFR 820.30(f)Design verification - documentation

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Other FDA inspections of Baxter Healthcare Corporation

Date	Classification	Office	Project area
April 2, 2026	Not classified	Chicago District Office	Drug Quality Assurance
November 25, 2025	Not classified	Chicago District Office	Blood and Blood Products
August 1, 2024	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
August 18, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 26, 2018	Not classified	Chicago District Office