The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Xanacare Lands 483 for Failure to Meet Specifications

Dec. 22, 2017
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The FDA faulted Xanacare Technologies of Denver, Colorado for not meeting specifications and for failing to qualify all suppliers.

The agency noted after an October inspection that the firm’s contract manufacturer for SimulCare II TENS, a temporary muscle and joint pain reliever, had a document of qualification that did not match the firm’s supplier or purchasing qualification standard operating procedures.

The facility also did not qualify all suppliers as required before using their services.

In addition, the company’s design history file for the SimulCareII TENS units failed to include documentation of design and development plans, design reviews or design transfer, and did not provide documentation showing the product was fit for the intended uses.

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