Fresco International 2005 S.A.
✅ Low Risk
FEI: 3005132313 • Barcelona, Barcelona • SPAIN
FEI Number
3005132313
Location
Barcelona, Barcelona
Country
SPAINAddress
Calle Sicilia 143, , Barcelona, 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
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).
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 Fresco International 2005 S.A.'s FDA import refusal history?
Fresco International 2005 S.A. (FEI: 3005132313) has 1 FDA import refusal record(s) in our database, spanning from 11/7/2005 to 11/7/2005.
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. Fresco International 2005 S.A.'s FEI number is 3005132313.
What types of violations has Fresco International 2005 S.A. received?
Fresco International 2005 S.A. 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 Fresco International 2005 S.A. come from?
All FDA import refusal data for Fresco International 2005 S.A. 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.