VENOME SPOLKA Z O. O
⚠️ High Risk
FEI: 3030663675 • Rodawska 25 • POLAND
FEI Number
3030663675
Location
Rodawska 25
Country
POLANDAddress
Poznan 61-312 Ul., , Rodawska 25, , Poland
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
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2025 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/20/2025 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2025 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2024 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VENOME SPOLKA Z O. O's FDA import refusal history?
VENOME SPOLKA Z O. O (FEI: 3030663675) has 4 FDA import refusal record(s) in our database, spanning from 9/11/2024 to 10/14/2025.
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. VENOME SPOLKA Z O. O's FEI number is 3030663675.
What types of violations has VENOME SPOLKA Z O. O received?
VENOME SPOLKA Z O. O 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 VENOME SPOLKA Z O. O come from?
All FDA import refusal data for VENOME SPOLKA Z O. O 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.