FDA EIR - 3M Company - Health Care Business - February 11, 2019

An FDA inspection of 3M Drug Delivery Systems Division in St. Paul, MN, was conducted from February 1 to February 11, 2019. This Post-marketing Adverse Drug Experience (PADE) reporting inspection, guided by FDA Compliance Program 7353.001, also verified corrective actions from a previous 2017 inspection. While 3M had largely addressed eight observations from the prior inspection regarding reporting and procedural deficiencies, the current inspection identified a new significant issue. A one-item FDA Form 483 was issued for the company’s failure to include individual Adverse Drug Experiences (ADEs) concerning "lack of effect" for their transdermal fentanyl product in periodic safety reports. Specifically, four out of 36 such complaints were misclassified as product quality complaints by a pharmacovigilance partner and not reported as adverse drug effects. In response, 3M management committed to implementing monthly reconciliations of ADE reports with their pharmacovigilance partner for a year, ensuring the partner provides FDA acknowledgment of submitted reports, and updating internal written procedures for handling post-market ADEs to include these periodic reconciliations. A Supplier Corrective Action Request was also issued to the partner to address the late reporting.