IMRES B.V.
⚠️ Moderate Risk
FEI: 3012465561 • Lelystad, Flevoland • NETHERLANDS
FEI Number
3012465561
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2017 | 79GDLNEEDLE, SUTURING, REUSABLE | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 56KCK10CHLORAMPHENICOL | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 65QAM37AMINOPHYLLINE (RELAXANT) | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 56BCC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 60SAK25RANITIDINE HYDROCHLORIDE (ANTACID) | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 63BCQ24BITOLTEROL MESYLATE (BRONCHODILATOR) | Division of Northeast Imports (DNEI) | |
| 6/15/2017 | 63XCY12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is IMRES B.V.'s FDA import refusal history?
IMRES B.V. (FEI: 3012465561) has 8 FDA import refusal record(s) in our database, spanning from 6/15/2017 to 6/15/2017.
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 B.V.'s FEI number is 3012465561.
What types of violations has IMRES B.V. received?
IMRES B.V. 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 B.V. come from?
All FDA import refusal data for IMRES B.V. 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.