INMUNOTEK SL
⚠️ High Risk
FEI: 3013553912 • Madrid • 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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/12/2023 | 57YH99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 9/19/2023 | 57HH99BACTERIAL VACCINES/ANTIGENS, N.E.C. | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 9/14/2023 | 57HH99BACTERIAL VACCINES/ANTIGENS, N.E.C. | 71NO LICENSE | Division of Northeast Imports (DNEI) |
| 8/18/2023 | 57HH99BACTERIAL VACCINES/ANTIGENS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/18/2023 | 66WDL99IMMUNOMODULATOR N.E.C. | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/1/2023 | 57CH99VIRAL VACCINES, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/28/2023 | 57HH99BACTERIAL VACCINES/ANTIGENS, N.E.C. | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 7/17/2023 | 66WDY99IMMUNOMODULATOR N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/4/2023 | 57IH99MULTIPLE VACCINE/MULTIPLEANTIGEN PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/13/2023 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INMUNOTEK SL's FDA import refusal history?
INMUNOTEK SL (FEI: 3013553912) has 10 FDA import refusal record(s) in our database, spanning from 3/13/2023 to 10/12/2023.
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. INMUNOTEK SL's FEI number is 3013553912.
What types of violations has INMUNOTEK SL received?
INMUNOTEK 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 INMUNOTEK SL come from?
All FDA import refusal data for INMUNOTEK 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.