FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Vector R&D Hit for Complaint Handling

Nov. 12, 2018
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Failure to establish adequate procedures for receiving, reviewing and evaluating complaints landed devicemaker Vector Research and Development in hot water with the FDA during a July 5 to July 8 inspection of its University Place, Washington plant, and resulted in a Form 483.

Vector R&D is an initial importer of dental equipment and repair parts. The firm’s Class II devices include the Victor LED Turbo curing light, the Little Beaver ultrasonic scaler and the MAXRAY mobile X-ray system.

The firm was unable to provide evidence of an investigation of non-conforming product or an evaluation for medical device reporting for four complaint files reviewed, the agency said.

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