Cochlear Bone Anchored Solutions AB
⚠️ Moderate Risk
FEI: 3003222064 • Molnlycke, Vastra Gotalands lan • SWEDEN
FEI Number
3003222064
Location
Molnlycke, Vastra Gotalands lan
Country
SWEDENAddress
Konstruktionsvagen 14, , Molnlycke, Vastra Gotalands lan, Sweden
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
Frequently Asked Questions
What is Cochlear Bone Anchored Solutions AB's FDA import refusal history?
Cochlear Bone Anchored Solutions AB (FEI: 3003222064) has 2 FDA import refusal record(s) in our database, spanning from 3/4/2008 to 3/10/2008.
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. Cochlear Bone Anchored Solutions AB's FEI number is 3003222064.
What types of violations has Cochlear Bone Anchored Solutions AB received?
Cochlear Bone Anchored Solutions AB 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 Cochlear Bone Anchored Solutions AB come from?
All FDA import refusal data for Cochlear Bone Anchored Solutions AB 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.