Acros Organics B.V.B.A.
⚠️ Moderate Risk
FEI: 3004856250 • Geel, Antwerp • BELGIUM
FEI Number
3004856250
Location
Geel, Antwerp
Country
BELGIUMAddress
Janssen-Pharmaceuticalaan 3a, Geel West, Zone 2, Geel, Antwerp, Belgium
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2022 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 6/28/2019 | 61WOY52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 8/31/2004 | 62IIY49PUROMYCIN HYDROCHLORIDE (ANTI-NEOPLASTIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Acros Organics B.V.B.A.'s FDA import refusal history?
Acros Organics B.V.B.A. (FEI: 3004856250) has 3 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 5/15/2022.
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. Acros Organics B.V.B.A.'s FEI number is 3004856250.
What types of violations has Acros Organics B.V.B.A. received?
Acros Organics B.V.B.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 Acros Organics B.V.B.A. come from?
All FDA import refusal data for Acros Organics B.V.B.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.