Becton Dickinson Medical (Singapore)
⚠️ Moderate Risk
FEI: 1000174591 • Singapore • SINGAPORE
FEI Number
1000174591
Location
Singapore
Country
SINGAPOREAddress
30 Tuas Avenue 2, , Singapore, , Singapore
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/21/2011 | 80KZHINTRODUCER, SYRINGE NEEDLE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/5/2007 | 80FMFSYRINGE, PISTON | New Orleans District Office (NOL-DO) | |
| 12/5/2007 | 80FMFSYRINGE, PISTON | New Orleans District Office (NOL-DO) | |
| 12/5/2007 | 80FMFSYRINGE, PISTON | New Orleans District Office (NOL-DO) | |
| 12/3/2007 | 80FMFSYRINGE, PISTON | New Orleans District Office (NOL-DO) | |
| 11/29/2007 | 80FMFSYRINGE, PISTON | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 11/29/2007 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 84RX DEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Becton Dickinson Medical (Singapore)'s FDA import refusal history?
Becton Dickinson Medical (Singapore) (FEI: 1000174591) has 7 FDA import refusal record(s) in our database, spanning from 11/29/2007 to 3/21/2011.
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 Medical (Singapore)'s FEI number is 1000174591.
What types of violations has Becton Dickinson Medical (Singapore) received?
Becton Dickinson Medical (Singapore) has been cited for 3 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 Medical (Singapore) come from?
All FDA import refusal data for Becton Dickinson Medical (Singapore) 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.