FDA EIR - Heron Therapeutics, Inc. - January 06, 2016

An FDA pre-approval inspection of Heron Therapeutics, Inc. was conducted from January 4-6, 2016, at their Redwood City, CA facility. This Level II Quality System Inspection Technique (QSIT) review was part of the approval process for Sustol (granisetron) Injection, ER, a drug-device combination product. The inspection assessed management control, corrective and preventive actions (CAPAs), design controls, and production and processing controls, aligning with established medical device quality system regulations. While no formal observations were issued, the inspection identified four key discussion items. These included the need for clearer documentation regarding the specific issues addressed by CAPAs, and more robust effectiveness checks for these actions. Additionally, the firm was advised on the importance of accurately identifying if a patient complaint occurred during treatment or diagnosis and ensuring timely filing of Medical Device Reports (MDRs). Heron Therapeutics management acknowledged these points and demonstrated immediate steps to address them, including updating CAPA forms and drafting new complaint and MDR procedures. The investigator reminded the firm of the ongoing need for continuous internal auditing to maintain quality system compliance.