FUJIFILM Diosynth Biotechnologies UK Limited
⚠️ Moderate Risk
FEI: 3007182567 • Billingham, Cleveland • UNITED KINGDOM
FEI Number
3007182567
Location
Billingham, Cleveland
Country
UNITED KINGDOMAddress
New Billingham House, Belasis Avenue, Billingham, Cleveland, United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2018 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/24/2018 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/24/2018 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/24/2018 | 66YIK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is FUJIFILM Diosynth Biotechnologies UK Limited's FDA import refusal history?
FUJIFILM Diosynth Biotechnologies UK Limited (FEI: 3007182567) has 4 FDA import refusal record(s) in our database, spanning from 4/24/2018 to 4/24/2018.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. FUJIFILM Diosynth Biotechnologies UK Limited's FEI number is 3007182567.
What types of violations has FUJIFILM Diosynth Biotechnologies UK Limited received?
FUJIFILM Diosynth Biotechnologies UK Limited has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about FUJIFILM Diosynth Biotechnologies UK Limited come from?
All FDA import refusal data for FUJIFILM Diosynth Biotechnologies UK Limited is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.