FDA 483 - MicroBiopharm Japan Co., Ltd. - September 13, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 15e359b0-2f23-43b2-b81c-518b5fa71258