Fujifilm Diosynth Biotechnologies USA, Inc.
Form 483 issued February 10, 2023 · North Carolina
- Inspection
- Feb 6 – Feb 10, 2023
- Investigators
- Jee Y. Chung· Patricia F. Hughes· Xiaoxiao Pan
- Observations
- 3
- Pages
- 1
- FEI number
- 3000718852
In short: On February 10, 2023, FDA issued a Form 483 with 3 observations to Fujifilm Diosynth Biotechnologies USA, Inc. in North Carolina (FEI 3000718852) after an inspection that ran Feb 6 – Feb 10, 2023. The investigators were Jee Y. Chung, Patricia F. Hughes and Xiaoxiao Pan. Most observations concern quality system and biologics CGMP.
At a glance
Quality system and biologics cgmp account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A quality agreement between the of the" and the drug substance manufacturer, Fujifilm…
- 02
Procedures for reporting biological product deviations for have not…
- 03
The purification process is intended to clear impurities, including endotoxin derived from the system. Studies have…
This inspection in context
Jee Y. Chung
5 documents · 2013–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.22
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 3 observations on this Form 483, mostly about quality system, biologics CGMP and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Fujifilm Diosynth Biotechnologies USA, Inc.?
Jee Y. Chung, Patricia F. Hughes and Xiaoxiao Pan are named on this Form 483, for the inspection of Feb 6 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Fujifilm Diosynth Biotechnologies USA, Inc. inspected by FDA?
The inspection ran Feb 6 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
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.