Orkla Care AB
⚠️ Moderate Risk
FEI: 3007624963 • Falun, Dalarnas Lan • SWEDEN
FEI Number
3007624963
Location
Falun, Dalarnas Lan
Country
SWEDENAddress
Skutuddsvagen 2, , Falun, Dalarnas 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
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).
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2018 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 2/28/2018 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 5/17/2013 | 62W09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | New England District Office (NWE-DO) |
Frequently Asked Questions
What is Orkla Care AB's FDA import refusal history?
Orkla Care AB (FEI: 3007624963) has 3 FDA import refusal record(s) in our database, spanning from 5/17/2013 to 2/28/2018.
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. Orkla Care AB's FEI number is 3007624963.
What types of violations has Orkla Care AB received?
Orkla Care AB has been cited for 3 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 Orkla Care AB come from?
All FDA import refusal data for Orkla Care 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.