Astellas Pharma Inc. – FDA 483, Mar 5, 2019

Astellas Pharma Tech Co Ltd in Takaoka City, Japan, was inspected by the FDA from February 25 to March 5, 2019, for its human drug product manufacturing. The inspection revealed significant deficiencies across multiple areas, including inadequate investigations into production deviations, failures in preventing microbiological contamination for sterile products, and issues with equipment maintenance and quality control procedures. These observations indicate a lack of robust controls to assure product quality, sterility, and data integrity.