Madespa S.A.
⚠️ Moderate Risk
FEI: 3003061923 • Toledo, Toledo • SPAIN
FEI Number
3003061923
Location
Toledo, Toledo
Country
SPAINAddress
Calle Jarama 120, , Toledo, Toledo, Spain
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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
RECORDS
The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
Refusal History
Frequently Asked Questions
What is Madespa S.A.'s FDA import refusal history?
Madespa S.A. (FEI: 3003061923) has 2 FDA import refusal record(s) in our database, spanning from 9/3/2010 to 11/10/2010.
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. Madespa S.A.'s FEI number is 3003061923.
What types of violations has Madespa S.A. received?
Madespa 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 Madespa S.A. come from?
All FDA import refusal data for Madespa 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.