CL- Tinters
⚠️ Moderate Risk
FEI: 3002397676 • Helsinki, Helsinki-Uusimaa • FINLAND
FEI Number
3002397676
Location
Helsinki, Helsinki-Uusimaa
Country
FINLANDAddress
Hoylaamotie 7, , Helsinki, Helsinki-Uusimaa, Finland
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).
COSM MISB
The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is CL- Tinters's FDA import refusal history?
CL- Tinters (FEI: 3002397676) has 2 FDA import refusal record(s) in our database, spanning from 5/26/2005 to 8/1/2005.
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. CL- Tinters's FEI number is 3002397676.
What types of violations has CL- Tinters received?
CL- Tinters has been cited for 4 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 CL- Tinters come from?
All FDA import refusal data for CL- Tinters 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.