Orkla Care AB
✅ Low Risk
FEI: 3000182940 • Solna, Stockholms Lan • SWEDEN
FEI Number
3000182940
Location
Solna, Stockholms Lan
Country
SWEDENAddress
Svetsarvagen 15, , Solna, Stockholms Lan, Sweden
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 |
|---|---|---|---|
| 6/14/2016 | 79KGXTAPE AND BANDAGE, ADHESIVE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Orkla Care AB's FDA import refusal history?
Orkla Care AB (FEI: 3000182940) has 1 FDA import refusal record(s) in our database, spanning from 6/14/2016 to 6/14/2016.
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 3000182940.
What types of violations has Orkla Care AB received?
Orkla Care 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 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.