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Medical Devices / Inspections and Audits

Quality System Failures Plague Texas-Based Ultrasonic Services

Nov. 28, 2018

The FDA found numerous quality system failures at Ultrasonic Services’ Houston, Texas facility during an Aug. 24 to Aug. 27 inspection.

The facility failed to analyze or document device failures following customer complaints about its USI 25 M and USI 25 MPLC Ultrasonic dental scalers, according to the agency’s Form 483 report.

The firm’s corrective and preventive action procedures also fell short in that numerous activities that should have triggered CAPA procedures did not do so, the agency said.

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