1Other quality system
Your unexplained discrepancies associated with your processes are not thoroughly investigated.
Inspection Record
Fujifilm Diosynth Biotechnologies USA Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
You have not ensured your microbiological methods are suitable for your operations.
3Equipment and facility
Facility design and procedural controls for manufacturing drug substance intended for commercial distribution do not provide adequate assurance against microbial contamination and cross-contamination risks in the manufacturing suite at your Fujifilm Diosynth Biotechnologies USA Durham facility.
4Other quality system
Your procedure for testing (b) (4) after use in your drug substance processing is inadequate in that in does not limit of times it could be tested.
About this record
Extracted automatically from the document US FDA published on 2026-07-10. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
