FUJIFILM Diosynth Biotechnologies Denmark ApS
Form 483 issued November 12, 2024 · Hillerod, Denmark
- Inspection
- Nov 4 – Nov 12, 2024
- Investigators
- David Anderson· Leiyun Boone· Mamta Kapoor-Bhushan
- Observations
- 3
- Pages
- 7
- FEI number
- 3006339887
In short: On November 12, 2024, FDA issued a Form 483 with 3 observations to FUJIFILM Diosynth Biotechnologies Denmark ApS in Hillerod, Denmark (FEI 3006339887) after an inspection that ran Nov 4 – Nov 12, 2024. The investigators were David Anderson, Leiyun Boone, Mamta Kapoor-Bhushan and Richard Ledwidge. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm’s Quality Unit’s oversight of your GMP manufacturing operations is inadequate. A) The Quality Unit…
- 02
Electronic records are used, but they do not meet authority check and audit trail requirements to…
- 03
Written production and process control procedures are not documented at…
This inspection in context
David Anderson
1 document · 2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Denmark.
The firmFUJIFILM Diosynth Biotechnologies Denmark ApS history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FUJIFILM Diosynth Biotechnologies Denmark ApS?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected FUJIFILM Diosynth Biotechnologies Denmark ApS?
David Anderson, Leiyun Boone, Mamta Kapoor-Bhushan and Richard Ledwidge are named on this Form 483, for the inspection of Nov 4 – Nov 12, 2024. Each investigator has a profile showing what they cite most.
When was FUJIFILM Diosynth Biotechnologies Denmark ApS inspected by FDA?
The inspection ran Nov 4 – Nov 12, 2024, and the Form 483 is dated November 12, 2024.
How do I get the full Form 483 for FUJIFILM Diosynth Biotechnologies Denmark ApS?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.