FDA 483 - MicroBiopharm Japan Co., Ltd. - September 13, 2019

MicroBiopharm Japan Co., Ltd., an API manufacturer in Iwata-shi, Japan, received a Form 483 for significant deficiencies in data integrity and quality system controls. The inspection revealed inadequate control over computerized systems, insufficient process controls to prevent microbiological contamination, and an inadequate quality management system. These issues indicate a lack of robust systems to ensure data reliability, product quality, and effective complaint and recall management.