Terumo Cardiovascular Systems Corporation
✅ Low Risk
FEI: 1828100 • Ann Arbor, MI • UNITED STATES
FEI Number
1828100
Location
Ann Arbor, MI
Country
UNITED STATESAddress
6200 Jackson Rd, , Ann Arbor, MI, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/26/2021 | 74DTQCONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Terumo Cardiovascular Systems Corporation's FDA import refusal history?
Terumo Cardiovascular Systems Corporation (FEI: 1828100) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2021 to 5/26/2021.
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. Terumo Cardiovascular Systems Corporation's FEI number is 1828100.
What types of violations has Terumo Cardiovascular Systems Corporation received?
Terumo Cardiovascular Systems Corporation 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 Terumo Cardiovascular Systems Corporation come from?
All FDA import refusal data for Terumo Cardiovascular Systems Corporation 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.