Ccs, Clean Chemical Sweden Ab
⚠️ Moderate Risk
FEI: 3005977754 • Borlange • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2007 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 8/14/2007 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 8/14/2007 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Ccs, Clean Chemical Sweden Ab's FDA import refusal history?
Ccs, Clean Chemical Sweden Ab (FEI: 3005977754) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2007 to 8/14/2007.
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. Ccs, Clean Chemical Sweden Ab's FEI number is 3005977754.
What types of violations has Ccs, Clean Chemical Sweden Ab received?
Ccs, Clean Chemical Sweden 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 Ccs, Clean Chemical Sweden Ab come from?
All FDA import refusal data for Ccs, Clean Chemical Sweden 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.