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Medical Devices / Inspections and Audits

Vector R&D Hit for Complaint Handling

Nov. 12, 2018

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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