FUJIFILM Diosynth Biotechnologies Denmark ApS
Form 483 issued July 8, 2016 · Hillerod, Denmark
- Inspection
- Jul 4 – Jul 8, 2016
- Investigators
- Christopher Downey· Ephrem Hunde· Wayne Seifert
- Observations
- 1
- Pages
- 1
- FEI number
- 3006339887
In short: On July 8, 2016, FDA issued a Form 483 with 1 observation to FUJIFILM Diosynth Biotechnologies Denmark ApS in Hillerod, Denmark (FEI 3006339887) after an inspection that ran Jul 4 – Jul 8, 2016. The investigators were Christopher Downey, Ephrem Hunde, Wayne Seifert and Xianghong Jing. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate procedure for laboratory…
This inspection in context
Christopher Downey
1 document · 2016
Cites 211.160 (general requirements) 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 211.160
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 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected FUJIFILM Diosynth Biotechnologies Denmark ApS?
Christopher Downey, Ephrem Hunde, Wayne Seifert and Xianghong Jing are named on this Form 483, for the inspection of Jul 4 – Jul 8, 2016. Each investigator has a profile showing what they cite most.
When was FUJIFILM Diosynth Biotechnologies Denmark ApS inspected by FDA?
The inspection ran Jul 4 – Jul 8, 2016, and the Form 483 is dated July 8, 2016.
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.