FDA EIR - IDT Biologika GmbH - October 18, 2012

An FDA product-specific Good Manufacturing Practices (GMP) inspection of IDT Biologika GmbH, a sterile drug manufacturer located in Dessau-Rosslau, Germany, was conducted from October 11-18, 2012. The inspection, requested by the Center for Drug Evaluation and Research (CDER), focused on the firm's Quality, Production, and Laboratory Systems, particularly concerning an injectable diluent. A key objective was to evaluate the company's implemented corrections to deficiencies cited during a previous inspection in 2010. Those prior issues included inadequate documentation of personnel monitoring, undocumented breaks for visual inspectors, insufficient disinfectant rotation, incomplete investigation of production deviations, inappropriate laboratory procedures, and inadequate incubator control. During this current inspection, auditors confirmed that all previously identified deficiencies had been adequately addressed and rectified. Consequently, no new deficiencies or objectionable conditions were found, no samples were collected, and no FDA-483 observations were issued. The company was found in substantial compliance with Good Manufacturing Practices, and its systems were deemed acceptable without further required actions.