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Medical Devices / Inspections and Audits

FDA Cites Azena Medical Over Complaint Investigations

Dec. 11, 2017

The FDA cited Azena Medical’s facility in Walnut Creek, California, following an October inspection.

The company failed to properly investigate complaints regarding the possible failure of its product Gemini Soft Tissue Laser to meet specifications.

One complaint stated the product’s tips had broken off, and a review of the complaint file revealed there was no documented investigation.

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