FUJIFILM Diosynth Biotechnologies Texas, LLC
Form 483 issued November 7, 2023 · College Station, Texas
- Inspection
- Oct 30 – Nov 7, 2023
- Observations
- 7
- Pages
- 6
- FEI number
- 3011948449
In short: On November 7, 2023, FDA issued a Form 483 with 7 observations to FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, Texas (FEI 3011948449) after an inspection that ran Oct 30 – Nov 7, 2023. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A standard operating procedure or plan in support of (b) (4) monoclonal antibody manufacture was not…
- 02
Your firm has not established adequate procedural controls over equipment systems in assurance of data…
- 03
The manufacturing process for (b) (4) manufacture…
- 04
Material management is deficient regarding the suitability of (b) (4) equipment to prevent contamination in the…
This inspection in context
Questions about this 483
What did FDA find at FUJIFILM Diosynth Biotechnologies Texas, LLC?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was FUJIFILM Diosynth Biotechnologies Texas, LLC inspected by FDA?
The inspection ran Oct 30 – Nov 7, 2023, and the Form 483 is dated November 7, 2023.
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.