1Stability and storage
The stability program SOP "FDBT-SOP-0405 (revision 10)" is not being followed.
Inspection Record
Fujifilm Diosynth Biotechnologies Texas, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Envlmnmeptal monitoring (EM) of classified processing areas in your[ (b><j acility for the (b)( >jntermediate manufacturing operations is deficient.
3Contamination control
Your cleaning and sanitization program is deficient in preventing potential contamination in the controlled drug substance manufacturing areas.
4Other quality system
SOPs or work instructions are not followed or are inadequate.
5Contamination control
Your multi-product manufacturing areas are not adequately controlled to prevent potential cross-contamination.
6Computer system validation
Your fir~ faited to exercise appropriate controls for the electronic data acquisition systems used forl Cb>< 4~intermediate manufacturing.
7Laboratory and QC controls
Your QC laboratory controls used for in-process, release, and stability testing ofj (b)(4J intermediate do not include appropriate test procedures that assure conformanc_e_t.&n" appropriate standards of QUalitv and 4c,urity.
About this record
Extracted automatically from the document US FDA published on 2026-04-29. 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.
