FUJIFILM Diosynth Biotechnologies Texas, LLC
Form 483 issued June 7, 2023 · College Station, Texas
- Inspection
- May 31 – Jun 7, 2023
- Investigator
- Lindsey Brown
- Observations
- 8
- Pages
- 8
- FEI number
- 3011948449
In short: On June 7, 2023, FDA issued a Form 483 with 8 observations to FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, Texas (FEI 3011948449) after an inspection that ran May 31 – Jun 7, 2023. The investigator was Lindsey Brown. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not fully followed |A. (6)…
- 02
Control procedures which validate the performance of those manufacturing process that may be responsible for causing…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
- 04
Failure to thoroughly review…
This inspection in context
Lindsey Brown
4 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Belgium.
The firmFUJIFILM Diosynth Biotechnologies Texas, LLC history
All 4 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 Texas, LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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 Texas, LLC?
Lindsey Brown is named on this Form 483, for the inspection of May 31 – Jun 7, 2023. Each investigator has a profile showing what they cite most.
When was FUJIFILM Diosynth Biotechnologies Texas, LLC inspected by FDA?
The inspection ran May 31 – Jun 7, 2023, and the Form 483 is dated June 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.