FDA 483 - Ultrasonic Services, Inc. - December 10, 2021

Ultrasonic Services, Inc. in Houston, TX, was inspected and received a Form FDA 483 with seven observations, many of which were repeat findings. The inspection revealed significant deficiencies across its quality system, including a complete lack of quality system procedures, uninvestigated complaints, missing device history records, and inadequate control over service reports, incoming products, suppliers, and equipment calibration. These issues indicate a severe breakdown in the firm's ability to ensure the quality and safety of its reconditioned/refurbished Class II medical devices, specifically Ultrasonic Dental Scalers.