FDA 483 - Pinnacle Biologics Inc - June 13, 2025

Pinnacle Biologics Inc, located in Bannockburn, IL, was inspected from June 10-13, 2025. The inspection revealed a significant issue with the firm's failure to submit Medical Device Reports (MDRs) within 30 days for device malfunctions, specifically broken fibers during Photodynamic Therapy (PDT) procedures. This indicates a serious lapse in reporting potentially harmful device issues that could cause or contribute to a death or serious injury if recurrent.