Fujifilm Diosynth Biotechnologies USA, Inc.
Form 483 issued April 21, 2021 · Morrisville, North Carolina
- Inspection
- Apr 14 – Apr 21, 2021
- Investigators
- Jacek Cieslak· Seneca Toms· Yun Wu
- Observations
- 10
- Pages
- 8
- FEI number
- 3000718852
In short: On April 21, 2021, FDA issued a Form 483 with 10 observations to Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, North Carolina (FEI 3000718852) after an inspection that ran Apr 14 – Apr 21, 2021. The investigators were Jacek Cieslak, Seneca Toms, Yun Wu and Zhihao Peter Qiu. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
Most cited: 21 CFR 211.42 (2×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no comprehensive risk assessments conducted at this multiproduct facility to justify the containment strategy…
- 02
The (b)(4) the (b)(4) manufacturing process is not adequately monitored and/or controlled to ensure the quality…
- 03
Procedures of material management systems are not…
- 04
You failed to establish adequate cleaning and sanitization procedures for non-dedicated product contact equipment at this…
This inspection in context
Jacek Cieslak
6 documents · 2019–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
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 211.42
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 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 USA, Inc.?
Jacek Cieslak, Seneca Toms, Yun Wu and Zhihao Peter Qiu are named on this Form 483, for the inspection of Apr 14 – Apr 21, 2021. Each investigator has a profile showing what they cite most.
When was Fujifilm Diosynth Biotechnologies USA, Inc. inspected by FDA?
The inspection ran Apr 14 – Apr 21, 2021, and the Form 483 is dated April 21, 2021.
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.