FDA EIR - Siegfried AG - June 14, 2019

An FDA routine surveillance inspection of Siegfried Ltd, located in Zofingen, Switzerland, was conducted from June 11-14, 2019. This inspection, governed by Compliance Program 7356.002F and ICH Q7A for Active Pharmaceutical Ingredients, assessed the firm's quality systems for drug substances distributed in the United States. Significantly, no formal inspectional observations (Form FDA 483) were issued, signifying the firm’s successful remediation of six observations from a previous January 2017 inspection. Those prior issues included deficiencies in equipment cleaning validations (microbiological and endotoxin control), a lack of retrospective investigations for process inadequacies, insufficient scientific justification for campaign production cleaning, inadequate audit trail review for analytical data, unsuitable water system sampling, and a flawed non-conforming results procedure. Siegfried Ltd demonstrated that comprehensive voluntary corrections, such as enhanced cleaning validation protocols, revised campaign length procedures, strengthened audit trail review processes, and corrected water system sampling, adequately addressed these concerns. During the 2019 inspection, minor concerns discussed with management included corrosion on a filling assembly, prompting an immediate work order, and an unrecorded room air pressure alarm, leading to a commitment to fully implement an automated building monitoring system. The firm maintained excellent cooperation throughout the inspection.