Beckman Coulter Biomedical Ltd.
⚠️ Moderate Risk
FEI: 3007830165 • Clare • IRELAND
FEI Number
3007830165
Location
Clare
Country
IRELANDAddress
Lismeehan, O'Callaghan'S Mills, , Clare, , 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2011 | 75KNKACID, URIC, URICASE (COLORIMETRIC) | Los Angeles District Office (LOS-DO) | |
| 2/28/2011 | 75CDQUREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN | Los Angeles District Office (LOS-DO) | |
| 2/28/2011 | 75KNKACID, URIC, URICASE (COLORIMETRIC) | Los Angeles District Office (LOS-DO) | |
| 2/28/2011 | 82DCNSYSTEM, TEST, C-REACTIVE PROTEIN | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Beckman Coulter Biomedical Ltd.'s FDA import refusal history?
Beckman Coulter Biomedical Ltd. (FEI: 3007830165) has 4 FDA import refusal record(s) in our database, spanning from 2/28/2011 to 2/28/2011.
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. Beckman Coulter Biomedical Ltd.'s FEI number is 3007830165.
What types of violations has Beckman Coulter Biomedical Ltd. received?
Beckman Coulter Biomedical Ltd. 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 Beckman Coulter Biomedical Ltd. come from?
All FDA import refusal data for Beckman Coulter Biomedical Ltd. 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.