Imres
⚠️ Moderate Risk
FEI: 3004432739 • Lelystad, Flevoland • NETHERLANDS
FEI Number
3004432739
Location
Lelystad, Flevoland
Country
NETHERLANDSAddress
Larserpoortweg 26, , Lelystad, Flevoland, Netherlands
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/9/2017 | 57YL99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C. | 71NO LICENSE | Division of Northern Border Imports (DNBI) |
| 6/28/2013 | 62OCB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | Atlanta District Office (ATL-DO) | |
| 6/28/2013 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Atlanta District Office (ATL-DO) | |
| 6/28/2013 | 62OCB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | Atlanta District Office (ATL-DO) | |
| 6/28/2013 | 79GAKSUTURE, ABSORBABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 6/28/2013 | 79GAKSUTURE, ABSORBABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 6/28/2013 | 79GAKSUTURE, ABSORBABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 6/7/2012 | 62VAJ99ANTI-VIRAL N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/28/2006 | 85MOLCONDOM, NON-LATEX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Imres's FDA import refusal history?
Imres (FEI: 3004432739) has 9 FDA import refusal record(s) in our database, spanning from 9/28/2006 to 6/9/2017.
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. Imres's FEI number is 3004432739.
What types of violations has Imres received?
Imres has been cited for 4 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 Imres come from?
All FDA import refusal data for Imres 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.