FUJIFILM Diosynth Biotechnologies Denmark ApS
Form 483 issued October 11, 2019 · Hillerod, Denmark
- Inspection
- Sep 23 – Oct 11, 2019
- Investigators
- Deborah Schmiel· Zhong Li
- Observations
- 5
- Pages
- 2
- FEI number
- 3006339887
In short: On October 11, 2019, FDA issued a Form 483 with 5 observations to FUJIFILM Diosynth Biotechnologies Denmark ApS in Hillerod, Denmark (FEI 3006339887) after an inspection that ran Sep 23 – Oct 11, 2019. The investigators were Deborah Schmiel and Zhong Li. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Your firm failed to adequately qualify the critical clean utility used for…
- 03
Your firm has not established adequate procedural controls to protect the…
- 04
Your firm lacks adequate assurance that the critical equipment and/or systems are maintained…
This inspection in context
Deborah Schmiel
5 documents · 2016–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in South Korea.
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 211.68
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 5 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected FUJIFILM Diosynth Biotechnologies Denmark ApS?
Deborah Schmiel and Zhong Li are named on this Form 483, for the inspection of Sep 23 – Oct 11, 2019. Each investigator has a profile showing what they cite most.
When was FUJIFILM Diosynth Biotechnologies Denmark ApS inspected by FDA?
The inspection ran Sep 23 – Oct 11, 2019, and the Form 483 is dated October 11, 2019.
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.