FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - April 21, 2021
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.
An FDA inspection of Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, NC, identified multiple significant deficiencies in their drug substance manufacturing operations. The firm failed to implement adequate risk assessments for cross-contamination, maintain proper process monitoring, and ensure robust material management and cleaning procedures. Furthermore, issues were noted in discrepancy investigations, microbial control, data integrity, and overall facility and equipment maintenance.
ID · 17d024ab-ac04-409b-9487-d3cc9484c5d4