FDA 483 - Shionogi Pharma Co. Ltd. - August 05, 2016

An FDA inspection of Shionogi Pharma Chemicals Co., Ltd. in Tokushima, Japan, revealed significant deficiencies across quality control, computerized systems, quality assurance, and manufacturing processes. The observations indicate a lack of robust data integrity controls, inadequate quality management system implementation, and insufficient process validation and documentation practices. These issues collectively suggest a moderate to severe level of non-compliance with cGMP regulations.