FUJIFILM Diosynth Biotechnologies Texas, LLC
Form 483 issued August 31, 2021 · College Station, Texas
- Inspection
- Aug 23 – Aug 31, 2021
- Observations
- 9
- Pages
- 5
- FEI number
- 3011948449
In short: On August 31, 2021, FDA issued a Form 483 with 9 observations to FUJIFILM Diosynth Biotechnologies Texas, LLC in College Station, Texas (FEI 3011948449) after an inspection that ran Aug 23 – Aug 31, 2021. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are not adequate controls to prevent cross-contamination of other products…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
Your firm is not following your contamination control strategy for product (b)@). Report, Microbial control of…
This inspection in context
Questions about this 483
What did FDA find at FUJIFILM Diosynth Biotechnologies Texas, LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
When was FUJIFILM Diosynth Biotechnologies Texas, LLC inspected by FDA?
The inspection ran Aug 23 – Aug 31, 2021, and the Form 483 is dated August 31, 2021.
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.