FUJIFILM Diosynth Biotechnologies Texas, LLC
FDA inspection history in College Station, Texas, 2021 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: two Form 483s; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–25Four Form 483s, at College Station, Texas.
- 2021The longest 483 on file: 9 observations over 5 pages at College Station, Texas.
Cited most
Across all FUJIFILM Diosynth Biotechnologies Texas observations on file
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.160General requirements4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
The complete FUJIFILM Diosynth Biotechnologies Texas file.
All 4 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
College Station, Texas
Four Form 483s · 2021 to 2025 · 32 observations
Latest: Form 483, Mar 11, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-03-11 | 483 Form 483 | College Station, Texas | 8 | $99 |
| 2023-11-07 | 483 Form 483 | College Station, Texas | 7 | $99 |
| 2023-06-07 | 483 Form 483 | College Station, Texas | 8 | $99 |
| 2021-08-31 | 483 Form 483 | College Station, Texas | 9 | $99 |
Investigators on these documents
Ayyappan Rathakrishnan (1)Jie He (1)Lindsey Brown (1)Mercy Oyugi (1)Yanyan Cao (1)Zhong Li (1)
FEI number 3011948449 · most recent document Mar 11, 2025
About FUJIFILM Diosynth Biotechnologies Texas, LLC
How many FDA Form 483s has FUJIFILM Diosynth Biotechnologies Texas, LLC received?
FDA Intel has 4 Form 483s on file for FUJIFILM Diosynth Biotechnologies Texas, LLC; the most recent is dated Mar 11, 2025.
When was FUJIFILM Diosynth Biotechnologies Texas, LLC last inspected by FDA?
The most recent FDA inspection document on file for FUJIFILM Diosynth Biotechnologies Texas, LLC is a Form 483 dated Mar 11, 2025, for the site in College Station, Texas.
What did FDA cite at FUJIFILM Diosynth Biotechnologies Texas, LLC?
The regulations cited most in the observations on file for FUJIFILM Diosynth Biotechnologies Texas, LLC are 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.