Boston Scientific Limited
⚠️ Moderate Risk
FEI: 3002806565 • Galway • IRELAND
FEI Number
3002806565
Location
Galway
Country
IRELANDAddress
Ballybrit Business Park, , Galway, , Ireland
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 10/3/2008 | 74NIQSTENT, CORONARY, DRUG-ELUTING | New England District Office (NWE-DO) | |
| 11/7/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | New York District Office (NYK-DO) |
| 8/30/2002 | 74MAFSTENT, CARDIOVASCULAR | 508NO 510(K) | New England District Office (NWE-DO) |
| 8/30/2002 | 74MAFSTENT, CARDIOVASCULAR | 508NO 510(K) | New England District Office (NWE-DO) |
| 8/30/2002 | 74MAFSTENT, CARDIOVASCULAR | 508NO 510(K) | New England District Office (NWE-DO) |
| 8/30/2002 | 74MAFSTENT, CARDIOVASCULAR | 508NO 510(K) | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Boston Scientific Limited's FDA import refusal history?
Boston Scientific Limited (FEI: 3002806565) has 17 FDA import refusal record(s) in our database, spanning from 8/30/2002 to 10/3/2008.
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. Boston Scientific Limited's FEI number is 3002806565.
What types of violations has Boston Scientific Limited received?
Boston Scientific Limited has been cited for 4 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 Boston Scientific Limited come from?
All FDA import refusal data for Boston Scientific 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.