GE Healthcare Biosciences – FDA EIR, Aug 6, 2012

An initial FDA inspection of GE Healthcare Biosciences in Westborough, MA, was conducted from July 30 to August 6, 2012. This unannounced baseline inspection, falling under the regulatory framework for Class II Medical Devices, focused on the company's 903™ Neonate Blood Collection Card, a device used for collecting dried blood spots for neonatal and adult screening. The inspection covered management, design, corrective and preventive action (CAPA), and production and process controls. While no formal FDA-483 Inspectional Observations were issued, two key discussion items were raised during the close-out meeting. First, Medical Device Report (MDR) event files submitted to the FDA often contained incomplete patient information without adequate explanation or documentation of efforts to obtain it; guidance on HIPAA compliance for reporters was provided. Second, the firm's customer complaint trending procedure was identified as lacking valid statistical techniques for establishing and verifying product characteristics, although the company still monitored and responded to individual complaints effectively. GE Healthcare Biosciences was receptive to addressing these items to enhance their quality system.