NEOPTOLEM SP ZOO
⚠️ Moderate Risk
FEI: 3030464492 • Wola Krzysztoporska, Lodzkie • POLAND
FEI Number
3030464492
Location
Wola Krzysztoporska, Lodzkie
Country
POLANDAddress
Ul. Rokszyce Drugie 87, , Wola Krzysztoporska, Lodzkie, Poland
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
TP NO PMTA
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.
TP NO SE
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
Refusal History
Frequently Asked Questions
What is NEOPTOLEM SP ZOO's FDA import refusal history?
NEOPTOLEM SP ZOO (FEI: 3030464492) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2025 to 7/24/2025.
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. NEOPTOLEM SP ZOO's FEI number is 3030464492.
What types of violations has NEOPTOLEM SP ZOO received?
NEOPTOLEM SP ZOO 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 NEOPTOLEM SP ZOO come from?
All FDA import refusal data for NEOPTOLEM SP ZOO 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.