FDA EIR - Azurity Pharmaceuticals, Inc. - December 20, 2017

An FDA inspection of CutisPharma, Inc., based in Wilmington, MA, was conducted between December 11 and December 20, 2017. The primary objective was to assess the company's preparedness for commercial manufacturing, adherence to its New Drug Application (NDA #208910 for Vancomycin Oral Solution Kit, marketed as FIRVANQ™), and overall data integrity. The inspection revealed two significant issues within the company's quality assurance framework. Firstly, the firm’s established sampling procedure for incoming active pharmaceutical ingredients (APIs) permitted composite sampling from multiple containers. Regulators highlighted that this method was inadequate to ensure the necessary level of assurance and compliance with industry standards. Individual sampling from each container was emphasized as critical. Secondly, investigators observed discrepancies in how the company followed its own general procedures for receiving raw materials, components, and labels. Furthermore, expired environmental monitoring plates were found in the API storage area refrigerator, signaling potential weaknesses in storage control and quality oversight. During the inspection close-out, CutisPharma management acknowledged these findings. The company is required to review and revise its sampling procedures to mandate individual sampling for incoming materials. Additionally, it must update its quality assurance protocols for material receipt, storage, and release to address the identified issues and ensure full compliance with internal standards and regulatory expectations.