BLANK WORKS SL
✅ Low Risk
FEI: 3024636436 • Vilassar De Mar, Barcelona • SPAIN
FEI Number
3024636436
Location
Vilassar De Mar, Barcelona
Country
SPAINAddress
Calle D'Enric Granados 150 Atico, , Vilassar De Mar, Barcelona, Spain
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.
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 BLANK WORKS SL's FDA import refusal history?
BLANK WORKS SL (FEI: 3024636436) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2022 to 10/28/2022.
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. BLANK WORKS SL's FEI number is 3024636436.
What types of violations has BLANK WORKS SL received?
BLANK WORKS SL 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 BLANK WORKS SL come from?
All FDA import refusal data for BLANK WORKS SL 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.