Covidien (formerly Mallinckrodt Medical)
⚠️ Moderate Risk
FEI: 3003382061 • Athlone, Co. WESTMEATH • IRELAND
FEI Number
3003382061
Location
Athlone, Co. WESTMEATH
Country
IRELANDAddress
Cornamaddy National School, , Athlone, Co. WESTMEATH, 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
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.
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
Frequently Asked Questions
What is Covidien (formerly Mallinckrodt Medical)'s FDA import refusal history?
Covidien (formerly Mallinckrodt Medical) (FEI: 3003382061) has 2 FDA import refusal record(s) in our database, spanning from 10/29/2001 to 10/12/2022.
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. Covidien (formerly Mallinckrodt Medical)'s FEI number is 3003382061.
What types of violations has Covidien (formerly Mallinckrodt Medical) received?
Covidien (formerly Mallinckrodt Medical) 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 Covidien (formerly Mallinckrodt Medical) come from?
All FDA import refusal data for Covidien (formerly Mallinckrodt Medical) 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.