FDA EIR - Daiichi Sankyo, Inc. - August 27, 2015

An FDA Pre-Approval and cGMP inspection was conducted at Daiichi Sankyo, Inc.'s Bethlehem, PA facility from August 24-27, 2015. This inspection, carried out under regulatory guidelines CP 7346.832 and CP 7356.002B, primarily evaluated the site's capability to perform stability testing for Tribenzor (NDA N200175/023), as it functions as a packaging facility. The review encompassed Quality, Laboratory, Facilities, and Packaging and Labeling Systems. While no formal FDA 483 Inspectional Observations were issued, the inspection revealed several verbal observations and issues. A notable concern was a consistent delay, ranging from 5 months to a year, in the Bethlehem site receiving complaint notifications from the corporate Quality Assurance department. Additionally, a specific shelf area within one stability chamber (STAB-001) did not meet required relative humidity specifications and was designated "not for cGMP use," necessitating remediation. The use of incorrect HPLC vials in the DSI Bethlehem laboratory also led to inaccurate dissolution results, a problem corrected by adopting certified screw-top vials. Further, the continuous monitoring system for the new stability laboratory's refrigerator/freezer units was noted as "not yet validated." Required actions for the firm include streamlining internal complaint notification processes, ensuring all stability chamber areas meet cGMP requirements, implementing stringent control over laboratory consumables like HPLC vials, validating laboratory monitoring systems, and enhancing new hire GMP training as agreed by management.