Faes Farma, S.A.
⚠️ High Risk
FEI: 3004044770 • Leioa, Bizkaia • SPAIN
FEI Number
3004044770
Location
Leioa, Bizkaia
Country
SPAINAddress
Avenida Autonomia 10, Barrio Lamiaco, , Leioa, Bizkaia, Spain
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/24/2024 | 61XCL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/17/2024 | 62GCY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2023 | 66SDH99VASODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2006 | 62GCP01ALCLOFENAC (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2005 | 60JDY01ARGININE GLUTAMATE (AMMONIA DETOXICANT) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Faes Farma, S.A.'s FDA import refusal history?
Faes Farma, S.A. (FEI: 3004044770) has 6 FDA import refusal record(s) in our database, spanning from 7/22/2005 to 10/27/2025.
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. Faes Farma, S.A.'s FEI number is 3004044770.
What types of violations has Faes Farma, S.A. received?
Faes Farma, 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 Faes Farma, S.A. come from?
All FDA import refusal data for Faes Farma, 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.