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Medical Devices / Inspections and Audits

Baxter Cited Over Product Controls, Acceptance Procedures

Dec. 27, 2017

The FDA cited Baxter Healthcare for failing to properly establish procedures for controlling processes and accepting incoming products.

The devicemaker’s facility in Medina, New York lacked adequate procedures for accepting incoming products and it failed to reject assemblies observed to be defective, as required by the company’s receiving inspection SOP.

The facility also lacked proper process control procedures, which resulted in inadequate cleaning of dispense tips, the agency said in a Form 483 report.

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