Fujifilm Diosynth Biotechnologies USA, Inc.
FDA inspection history across 3 sites, 2015 to 2026
- 5
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2019: one Form 483; 2021: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at North Carolina.
- 2019–23Three Form 483s, at Morrisville, North Carolina and North Carolina.
- 2021The longest 483 on file: 10 observations over 8 pages at Morrisville, North Carolina.
- 2026One Form 483, at Research Triangle Park, North Carolina.
Cited most
Across all Fujifilm Diosynth Biotechnologies USA observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.160General requirements4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
The complete Fujifilm Diosynth Biotechnologies USA file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
North Carolina
Two Form 483s · 2015 to 2023 · 13 observations
Latest: Form 483, Feb 10, 2023 →Morrisville, North Carolina
Two Form 483s · 2019 to 2021 · 10 observations
Latest: Form 483, Apr 21, 2021 →Research Triangle Park, North Carolina
One Form 483 · 2026 · 1 observation
Latest: Form 483, Mar 27, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-27 | 483 Form 483 | Research Triangle Park, North Carolina | 1 | $99 |
| 2023-02-10 | 483 Form 483 | North Carolina | 3 | $99 |
| 2021-04-21 | 483 Form 483 | Morrisville, North Carolina | 10 | $99 |
| 2019-03-01 | 483 Form 483 | Morrisville, North Carolina | — | $99 |
| 2015-05-01 | 483 Form 483 | North Carolina | 10 | $99 |
Investigators on these documents
Amy Devlin (1)Andrea A. Munroe (1)Bo Chi (1)Jacek Cieslak (1)Jee Y. Chung (1)Kayla V. Sprague (1)Leopold Kong (1)Patricia F. Hughes (1)Pli Oe (1)Seneca Toms (1)Veronica Fuentes (1)Xiaoxiao Pan (1)
FEI number 3000718852 · most recent document Mar 27, 2026
About Fujifilm Diosynth Biotechnologies USA, Inc.
How many FDA Form 483s has Fujifilm Diosynth Biotechnologies USA, Inc. received?
FDA Intel has 5 Form 483s on file for Fujifilm Diosynth Biotechnologies USA, Inc.; the most recent is dated Mar 27, 2026.
When was Fujifilm Diosynth Biotechnologies USA, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Fujifilm Diosynth Biotechnologies USA, Inc. is a Form 483 dated Mar 27, 2026, for the site in Research Triangle Park, North Carolina.
What did FDA cite at Fujifilm Diosynth Biotechnologies USA, Inc.?
The regulations cited most in the observations on file for Fujifilm Diosynth Biotechnologies USA, Inc. are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.100 (Written procedures; deviations), 4 times; 21 CFR 211.160 (General requirements), 4 times.