Skillingardsalvan Ab
⚠️ Moderate Risk
FEI: 3010985479 • Skillingaryd, J�nk�pings L�n • SWEDEN
FEI Number
3010985479
Location
Skillingaryd, J�nk�pings L�n
Country
SWEDENAddress
Box 38, , Skillingaryd, J�nk�pings L�n, 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).
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
Frequently Asked Questions
What is Skillingardsalvan Ab's FDA import refusal history?
Skillingardsalvan Ab (FEI: 3010985479) has 1 FDA import refusal record(s) in our database, spanning from 9/12/2014 to 9/12/2014.
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. Skillingardsalvan Ab's FEI number is 3010985479.
What types of violations has Skillingardsalvan Ab received?
Skillingardsalvan Ab 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 Skillingardsalvan Ab come from?
All FDA import refusal data for Skillingardsalvan 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.