FUJIFILM Diosynth Biotechnologies UK Limited FDA Record
- Latest inspection VAI · Mar 17, 2023
- No warning letters matched by name
FUJIFILM Diosynth Biotechnologies UK Limited has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "FUJIFILM Diosynth Biotechnologies UK Limited" is on file.
- Latest inspection
- Mar 17, 2023 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 6 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
FUJIFILM Diosynth Biotechnologies UK Limited: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 17, 2023 | Billingham, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3007182567 |
| Mar 25, 2021 | Billingham, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3007182567 |
| Nov 16, 2018 | Billingham, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3007182567 |
| Jul 11, 2014 | Billingham, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3007182567 |
| Jun 20, 2012 | Billingham, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3007182567 |
| Jan 9, 2009 | Billingham, United Kingdom | Drugs | Voluntary Action Indicated (VAI) | 3007182567 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007182567 | Billingham, United Kingdom | 6 | Mar 17, 2023 |
FUJIFILM Diosynth Biotechnologies UK Limited and the FDA: common questions
Has FUJIFILM Diosynth Biotechnologies UK Limited received an FDA warning letter?
No FDA warning letter addressed to the name "FUJIFILM Diosynth Biotechnologies UK Limited" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has FUJIFILM Diosynth Biotechnologies UK Limited received an FDA Form 483?
FDA has not published a Form 483 for "FUJIFILM Diosynth Biotechnologies UK Limited" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect FUJIFILM Diosynth Biotechnologies UK Limited?
The most recent FDA inspection on file ended Mar 17, 2023 at Billingham, United Kingdom and was classified VAI. FDA has 6 inspections of FUJIFILM Diosynth Biotechnologies UK Limited on file.
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