FDA 483 - Pinnacle Biologics Inc - June 27, 2022

Pinnacle Biologics Inc, a specification developer in Bannockburn, IL, received a Form 483 for deficiencies in its medical device reporting and complaint handling procedures. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe and did not adequately evaluate or investigate complaints, particularly those related to its Photodynamic Therapy (PDT) combination product. These issues indicate a lack of robust quality system controls for post-market surveillance.