FDA EIR - Unknown Company - December 20, 2017

A U.S. Food and Drug Administration (FDA) pre-approval inspection of CutisPharma, Inc., located in Wilmington, MA, was conducted from December 11 to December 20, 2017. The inspection focused on the company's readiness for commercial manufacturing and compliance with their New Drug Application (NDA #208910) for Firvanq

(Vancomycin Oral Solution Kit), a product manufactured by their subsidiary, RxM Therapeutics, LLC. The regulatory framework for this inspection included adherence to relevant Compliance Program Guidance Manuals for drug product inspections.

While many aspects of the company's quality management system, including training, manufacturing operations, facilities, and equipment, were reviewed without significant adverse findings, two key issues were identified during the closing meeting. Firstly, the firm's sampling procedure for incoming Active Pharmaceutical Ingredients (API) allowed composite sampling from multiple containers, which the FDA noted as insufficient for ensuring adequate assurance and consistency. Secondly, expired plates were found in the refrigerator within the API storage area, highlighting a deficiency in Quality Assurance oversight for critical supplies.

As a result, the FDA required CutisPharma's management to review and update their sampling procedures for incoming materials to ensure individual sampling of critical components. Additionally, the company was directed to enhance their Quality Assurance procedures concerning the receipt, storage, and release of critical supplies to prevent the presence of expired items. The inspection concluded with the firm acknowledging these concerns and committing to update their procedures.