Becton Dickinson Infusion Therapy UK
⚠️ Moderate Risk
FEI: 3001741852 • Swindon • UNITED KINGDOM
FEI Number
3001741852
Location
Swindon
Country
UNITED KINGDOMAddress
Fararday Road, , Swindon, , 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
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
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 |
|---|---|---|---|
| 4/27/2016 | 80KZHINTRODUCER, SYRINGE NEEDLE | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 1/8/2005 | 80FMFSYRINGE, PISTON | 3081INVDEVICE | Chicago District Office (CHI-DO) |
| 12/21/2004 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | 3081INVDEVICE | Chicago District Office (CHI-DO) |
| 12/16/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 3081INVDEVICE | Chicago District Office (CHI-DO) |
| 12/16/2004 | 80FMFSYRINGE, PISTON | 3081INVDEVICE | Chicago District Office (CHI-DO) |
| 12/16/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 3081INVDEVICE | Chicago District Office (CHI-DO) |
| 12/16/2004 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 3081INVDEVICE | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Becton Dickinson Infusion Therapy UK's FDA import refusal history?
Becton Dickinson Infusion Therapy UK (FEI: 3001741852) has 7 FDA import refusal record(s) in our database, spanning from 12/16/2004 to 4/27/2016.
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. Becton Dickinson Infusion Therapy UK's FEI number is 3001741852.
What types of violations has Becton Dickinson Infusion Therapy UK received?
Becton Dickinson Infusion Therapy UK has been cited for 2 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 Becton Dickinson Infusion Therapy UK come from?
All FDA import refusal data for Becton Dickinson Infusion Therapy UK 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.