In short: On May 1, 2015, FDA issued a Form 483 with 10 observations to Fujifilm Diosynth Biotechnologies USA, Inc. in North Carolina (FEI 3000718852) after an inspection that ran Apr 27, 2014 – May 1, 2015. The investigators were Bo Chi and Pli Oe. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There were multiple instances of filters clogging during h_ TT…
- 02
Operating ranges for multiple process parameters for TT: 2 substance manufacturing were not adequately established prior…
- 03
Biotechnologies and the manufacturing…
- 04
The batch record foi loes not provide instructions in the event that…
This inspection in context
Bo Chi
8 documents · 2013–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
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 211.100
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 production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Fujifilm Diosynth Biotechnologies USA, Inc.?
Bo Chi and Pli Oe are named on this Form 483, for the inspection of Apr 27, 2014 – May 1, 2015. Each investigator has a profile showing what they cite most.
When was Fujifilm Diosynth Biotechnologies USA, Inc. inspected by FDA?
The inspection ran Apr 27, 2014 – May 1, 2015, and the Form 483 is dated May 1, 2015.
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.