FDA EIR - Bora Pharmaceuticals Inc. - June 21, 2018

Upsher Smith Laboratories, Inc. underwent a routine FDA inspection from June 20-21, 2018, at its Maple Grove, MN facility. The inspection's primary focus was Postmarketing Adverse Event Drug Experience (PADE) reporting for human drug and dietary supplement products, conducted under Compliance Program 7353.001. During this two-day inspection, a comprehensive review of the company's adverse event processes was performed. This included examination of individual case safety reports, periodic reports, written procedures, safety data exchange agreements, and the firm's system for contracting out adverse event handling to a third-party vendor. The FDA noted that all previous observations from a 2014 PADE inspection, which had resulted in a "Voluntary Action Indicated" classification due to issues like undocumented PADE training and procedural gaps, were observed to have been corrected. Crucially, no Form FDA-483 (Inspectional Observations) was issued, nor were any verbal issues discussed with management at the conclusion of the June 2018 inspection. The FDA found no failures in adhering to written procedures or instances of late expedited reporting. The firm demonstrated a compliant status, having implemented a robust pharmacovigilance system, including a thoroughly assessed third-party vendor for adverse event processing. Consequently, no new regulatory actions were required from Upsher Smith Laboratories, Inc.