Fujifilm Diosynth Biotechnologies USA, Inc.
Form 483 issued March 27, 2026 · Research Triangle Park, North Carolina
- Inspection
- Mar 23 – Mar 27, 2026
- Investigators
- Andrea A. Munroe· Kayla V. Sprague· Veronica Fuentes
- Observations
- 1
- Pages
- 5
- FEI number
- 3000718852
In short: On March 27, 2026, FDA issued a Form 483 with 1 observation to Fujifilm Diosynth Biotechnologies USA, Inc. in Research Triangle Park, North Carolina (FEI 3000718852) after an inspection that ran Mar 23 – Mar 27, 2026. The investigators were Andrea A. Munroe, Kayla V. Sprague and Veronica Fuentes. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Facility design and procedural controls for manufacturing drug substance intended for commercial distribution do not provide…
This inspection in context
Andrea A. Munroe
1 document · 2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmFujifilm Diosynth Biotechnologies USA, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fujifilm Diosynth Biotechnologies USA, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Fujifilm Diosynth Biotechnologies USA, Inc.?
Andrea A. Munroe, Kayla V. Sprague and Veronica Fuentes are named on this Form 483, for the inspection of Mar 23 – Mar 27, 2026. Each investigator has a profile showing what they cite most.
When was Fujifilm Diosynth Biotechnologies USA, Inc. inspected by FDA?
The inspection ran Mar 23 – Mar 27, 2026, and the Form 483 is dated March 27, 2026.
How do I get the full Form 483 for Fujifilm Diosynth Biotechnologies USA, Inc.?
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.