FUJIFILM Diosynth Biotechnologies Denmark ApS
FDA inspection history in Hillerod, Denmark, 2016 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Hillerod, Denmark.
- 2019One Form 483, at Hillerod, Denmark.
- 2019The longest 483 on file: 5 observations over 2 pages at Hillerod, Denmark.
- 2024One Form 483, at Hillerod, Denmark.
Cited most
Across all FUJIFILM Diosynth Biotechnologies Denmark ApS observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
The complete FUJIFILM Diosynth Biotechnologies Denmark ApS file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hillerod, Denmark
Three Form 483s · 2016 to 2024 · 9 observations
Latest: Form 483, Nov 12, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-12 | 483 Form 483 | Hillerod, Denmark | 3 | $99 |
| 2019-10-11 | 483 Form 483 | Hillerod, Denmark | 5 | $99 |
| 2016-07-08 | 483 Form 483 | Hillerod, Denmark | 1 | $99 |
Investigators on these documents
Christopher Downey (1)David Anderson (1)Deborah Schmiel (1)Ephrem Hunde (1)Leiyun Boone (1)Mamta Kapoor-Bhushan (1)Richard Ledwidge (1)Wayne Seifert (1)Xianghong Jing (1)Zhong Li (1)
FEI number 3006339887 · most recent document Nov 12, 2024
About FUJIFILM Diosynth Biotechnologies Denmark ApS
How many FDA Form 483s has FUJIFILM Diosynth Biotechnologies Denmark ApS received?
FDA Intel has 3 Form 483s on file for FUJIFILM Diosynth Biotechnologies Denmark ApS; the most recent is dated Nov 12, 2024.
When was FUJIFILM Diosynth Biotechnologies Denmark ApS last inspected by FDA?
The most recent FDA inspection document on file for FUJIFILM Diosynth Biotechnologies Denmark ApS is a Form 483 dated Nov 12, 2024, for the site in Hillerod, Denmark.
What did FDA cite at FUJIFILM Diosynth Biotechnologies Denmark ApS?
The regulations cited most in the observations on file for FUJIFILM Diosynth Biotechnologies Denmark ApS are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time.