CMP Pharma Inc – FDA EIR, Dec 21, 2016

An FDA inspection of CMP Pharma Inc. was conducted from December 19-21, 2016, focusing on the company’s compliance with Post marketing Adverse Drug Experience (PADE) reporting regulations. The inspection assessed the firm's adherence to adverse drug experience (ADE) laws and regulations, specifically referencing 21 CFR 314.80.

Two significant observations were noted. Firstly, the company failed to report individual ADEs to the FDA, either as 15-day alerts or within periodic safety reports. Specifically, three complaints accompanied by MEDWATCH forms and one "lack of effect" report were not submitted. Secondly, CMP Pharma Inc. lacked comprehensive written procedures for managing post marketing adverse drug experiences. This included inadequate instructions for documenting initial ADE receipt dates and identifying ADEs from various internal sources, such as product complaints.

During discussions, management acknowledged the issues and committed to submitting the previously omitted adverse event reports. They also initiated revisions to the product complaint procedure (SOP 107) to explicitly address ADEs, and agreed to enhance the ADE reporting procedure (SOP 105) to provide clearer guidance on internal intake processes and consistent date documentation with their pharmacovigilance contractor. Furthermore, the inspection highlighted the absence of formal training for in-house personnel on handling ADEs and the need for a documented procedure outlining responsibilities for outsourced electronic submissions, emphasizing the firm’s overall responsibility for regulatory compliance.