Patheon Pharmaceuticals Inc. – FDA 483, Aug 21, 2015

Patheon Pharmaceuticals Inc. in Cincinnati, OH, a manufacturer, was cited for significant data integrity and procedural compliance issues during an FDA inspection. Observations included a lack of complete audit trails for networked HPLC testing and unrecorded sample injections, failure to follow standard operating procedures for chromatography data systems, and inadequate checks for computer input/output accuracy in manufacturing. These findings indicate serious deficiencies in record-keeping and adherence to established controls.