H C Clover Productos Y Servicios SL
⚠️ Moderate Risk
FEI: 3011657196 • Arganda Del Rey, Madrid • SPAIN
FEI Number
3011657196
Location
Arganda Del Rey, Madrid
Country
SPAINAddress
Calle Alicante 8-10, , Arganda Del Rey, Madrid, 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
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is H C Clover Productos Y Servicios SL's FDA import refusal history?
H C Clover Productos Y Servicios SL (FEI: 3011657196) has 1 FDA import refusal record(s) in our database, spanning from 3/18/2024 to 3/18/2024.
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. H C Clover Productos Y Servicios SL's FEI number is 3011657196.
What types of violations has H C Clover Productos Y Servicios SL received?
H C Clover Productos Y Servicios 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 H C Clover Productos Y Servicios SL come from?
All FDA import refusal data for H C Clover Productos Y Servicios 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.