Faaborg Rehab Technic Aps
⚠️ Moderate Risk
FEI: 3004132708 • Faaborg, Syddanmark • DENMARK
FEI Number
3004132708
Location
Faaborg, Syddanmark
Country
DENMARKAddress
Smedemestervej 9, , Faaborg, Syddanmark, Denmark
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2014 | 89IORWHEELCHAIR, MECHANICAL | New Orleans District Office (NOL-DO) | |
| 4/15/2011 | 80FMRDEVICE, TRANSFER, PATIENT, MANUAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 1/28/2011 | 80FSALIFT, PATIENT, NON-AC-POWERED | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 11/3/2004 | 80FMRDEVICE, TRANSFER, PATIENT, MANUAL | 2780DEVICEGMPS | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Faaborg Rehab Technic Aps's FDA import refusal history?
Faaborg Rehab Technic Aps (FEI: 3004132708) has 4 FDA import refusal record(s) in our database, spanning from 11/3/2004 to 5/9/2014.
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. Faaborg Rehab Technic Aps's FEI number is 3004132708.
What types of violations has Faaborg Rehab Technic Aps received?
Faaborg Rehab Technic Aps 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 Faaborg Rehab Technic Aps come from?
All FDA import refusal data for Faaborg Rehab Technic Aps 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.