ALCHEMY INTERNATIONAL TRADE S.A
⚠️ Moderate Risk
FEI: 3024082497 • Almoradi, Alicante • SPAIN
FEI Number
3024082497
Location
Almoradi, Alicante
Country
SPAINAddress
Avenida El Banet N 2, , Almoradi, Alicante, 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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 ALCHEMY INTERNATIONAL TRADE S.A's FDA import refusal history?
ALCHEMY INTERNATIONAL TRADE S.A (FEI: 3024082497) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2022 to 10/25/2022.
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. ALCHEMY INTERNATIONAL TRADE S.A's FEI number is 3024082497.
What types of violations has ALCHEMY INTERNATIONAL TRADE S.A received?
ALCHEMY INTERNATIONAL TRADE S.A has been cited for 3 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 ALCHEMY INTERNATIONAL TRADE S.A come from?
All FDA import refusal data for ALCHEMY INTERNATIONAL TRADE 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.