FUJIFILM Diosynth Biotechnologies Texas, LLC
Form 483 issued March 11, 2025 · College Station, Texas
- Inspection
- Mar 4 – Mar 11, 2025
- Investigators
- Ayyappan Rathakrishnan· Jie He· Mercy Oyugi
- Observations
- 8
- Pages
- 7
- FEI number
- 3011948449
In short: On March 11, 2025, FDA issued a Form 483 with 8 observations to FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, Texas (FEI 3011948449) after an inspection that ran Mar 4 – Mar 11, 2025. The investigators were Ayyappan Rathakrishnan, Jie He, Mercy Oyugi, Yanyan Cao and Zhong Li. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 8 observations.
Most cited: 21 CFR 211.42 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your multi-product manufacturing areas are not adequately controlled…
- 02
Your QC laboratory controls used for in-process, release, and stability testing of intermediate do not include…
- 03
The stability program SOP “FDBT-SOP-0405 (revision 10)” is not being followed. The SOP requires that stability…
- 04
Your cleaning and sanitization program is deficient in preventing potential contamination in the controlled drug substance…
This inspection in context
Ayyappan Rathakrishnan
2 documents · 2024–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Belgium.
The firmFUJIFILM Diosynth Biotechnologies Texas, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FUJIFILM Diosynth Biotechnologies Texas, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected FUJIFILM Diosynth Biotechnologies Texas, LLC?
Ayyappan Rathakrishnan, Jie He, Mercy Oyugi, Yanyan Cao and Zhong Li are named on this Form 483, for the inspection of Mar 4 – Mar 11, 2025. Each investigator has a profile showing what they cite most.
When was FUJIFILM Diosynth Biotechnologies Texas, LLC inspected by FDA?
The inspection ran Mar 4 – Mar 11, 2025, and the Form 483 is dated March 11, 2025.
How do I get the full Form 483 for FUJIFILM Diosynth Biotechnologies Texas, LLC?
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.