FDA EIR - Sound Technology Inc - March 17, 2016

The FDA conducted a Level II Quality System Inspection Technique (QSIT) inspection of Sound Technology Inc (STI), a medical device contract manufacturer of Class II ultrasound probes, from March 16-17, 2016, in State College, PA. The inspection, guided by the regulatory framework for medical device manufacturers (CP7382.845), covered critical areas including Management Controls, Production and Process Controls, Corrective and Preventive Actions, and Design Controls.

Key observations from the inspection focused on three main areas. Firstly, STI failed to complete formal supplier evaluations for all critical component suppliers, specifically for Analogic Shanghai, a related entity. This oversight was noted despite numerous incoming inspection nonconformances from this supplier. Secondly, during a review of Device History Records, instances of incorrect data were found that were not properly corrected or documented according to company procedures (e.g., incorrect dates not lined out, dated, or initialed). Lastly, descriptions within nonconformance logs were deemed inadequate, lacking sufficient detail to easily identify the nature of the issue without further research.

In response, company management committed to rectifying these issues. They agreed to implement supplier evaluations for Analogic Shanghai, retrain employees on proper documentation practices for record keeping, and enhance the detail and clarity of nonconformance descriptions to ensure better understanding and traceability.