FDA EIR - Steven Label Corporation - May 08, 2009

An FDA post-market and abbreviated Quality System Inspection Technique (QSIT) inspection of Steven Label Corporation, located in Santa Fe Springs, CA, occurred between May 5 and May 8, 2009. The inspection focused on the company's role as a component manufacturer, specifically for the Navigator Sensor Sheet, which is part of a Class III finished medical device. The regulatory framework for this inspection adhered to CP 7383.001 for Medical Device Premarket Approval and Postmarket Inspections, and CP 7382.845 for Inspection of Medical Device Manufacturers. While no FDA-483 was issued, the inspection identified two primary observations. A significant finding was the absence of documented recall procedures, which are essential for a medical device component manufacturer. Additionally, a crucial "cleaning" step performed on the Navigator Sensor Sheet prior to packaging lacked formal inclusion in the company's written manufacturing procedures. Although Steven Label stated this step was performed based on external guidance, the investigator recommended either formally documenting this procedure within their quality system or providing a documented rationale for its exclusion. Management expressed agreement to take appropriate action to address this documentation deficiency. The inspection also confirmed the satisfactory implementation of voluntary corrections from a previous review, particularly concerning employee training and refining process control language.