Fujifilm Diosynth Biotechnologies USA, Inc.
Form 483 issued March 1, 2019 · Morrisville, North Carolina
- Investigators
- Amy Devlin· Leopold Kong
- Observations
- 2
- Pages
- 1
- FEI number
- 3000718852
In short: On March 1, 2019, FDA issued a Form 483 with 2 observations to Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, North Carolina (FEI 3000718852). The investigators were Amy Devlin and Leopold Kong. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Bioburden testing method for PPQ batches…
- 02
Inadequate investigation of…
This inspection in context
Amy Devlin
4 documents · 2019–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Illinois.
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 211.160
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 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Fujifilm Diosynth Biotechnologies USA, Inc.?
Amy Devlin and Leopold Kong are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Fujifilm Diosynth Biotechnologies USA, Inc. inspected by FDA?
This Form 483 is dated March 1, 2019.
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.