FUJIFILM Diosynth Biotechnologies UK Ltd
Form 483 issued March 17, 2023 · Billingham, United Kingdom
- Inspection
- Mar 13 – Mar 17, 2023
- Investigator
- Libia M. Lugo
- Observations
- 1
- Pages
- 2
- FEI number
- 3007182567
In short: On March 17, 2023, FDA issued a Form 483 with 1 observation to FUJIFILM Diosynth Biotechnologies UK Ltd in Billingham, United Kingdom (FEI 3007182567) after an inspection that ran Mar 13 – Mar 17, 2023. The investigator was Libia M. Lugo. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your established process controls were unable to prevent contamination of drug substances during manufacturing processes at…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmFUJIFILM Diosynth Biotechnologies UK Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FUJIFILM Diosynth Biotechnologies UK Ltd?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected FUJIFILM Diosynth Biotechnologies UK Ltd?
Libia M. Lugo is named on this Form 483, for the inspection of Mar 13 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was FUJIFILM Diosynth Biotechnologies UK Ltd inspected by FDA?
The inspection ran Mar 13 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
How do I get the full Form 483 for FUJIFILM Diosynth Biotechnologies UK Ltd?
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.