Swedencare Ab
⚠️ Moderate Risk
FEI: 3007381147 • Kiruna, Norrbottens Lan • SWEDEN
FEI Number
3007381147
Location
Kiruna, Norrbottens Lan
Country
SWEDENAddress
Bjorkstigen 9, , Kiruna, Norrbottens 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2011 | 68Y10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/20/2011 | 68Y10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/20/2011 | 68Y99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/20/2011 | 68Y10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/20/2011 | 66YBH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 12/20/2011 | 68Y10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Swedencare Ab's FDA import refusal history?
Swedencare Ab (FEI: 3007381147) has 6 FDA import refusal record(s) in our database, spanning from 12/20/2011 to 12/20/2011.
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. Swedencare Ab's FEI number is 3007381147.
What types of violations has Swedencare Ab received?
Swedencare 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 Swedencare Ab come from?
All FDA import refusal data for Swedencare 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.