Leading Pharma, LLC – FDA EIR, Aug 11, 2020

An FDA surveillance inspection of Leading Pharma, LLC, located in Fairfield, NJ, was conducted from August 3-11, 2020. The inspection focused on Postmarketing Adverse Drug Experience (PADE) activities under Compliance Program 7356.002 and 21 CFR 314.80. Key findings included an inadequate Safety Data Exchange Agreement (SDEA) with a third-party contractor, specifically regarding the timeframe for reporting serious adverse events during holidays and an incorrect definition of 'Calendar Day 0'. The company also submitted one expedited safety report and one Periodic Adverse Drug Experience Report (PADER) late. Additionally, the reconciliation tracker between Leading Pharma and its drug safety vendor was incomplete, lacking consistent updates for open cases. An outdated Standard Operating Procedure (SOP) was identified, which still required FDA Form 3500A and copies of individual case safety reports (ICSRs) within PADERs, although this practice had recently been corrected. No FDA Form 483 (Inspectional Observations) was issued. Leading Pharma's management acknowledged these findings and committed to correcting all identified issues, including reviewing and updating SDEAs, clarifying definitions, improving reconciliation processes for ICSRs, ensuring timely PADER submissions, and updating relevant SOPs to reflect current regulatory requirements.