FIRMA HANDLOWO-USLUGOWA GABRIEL
⚠️ Moderate Risk
FEI: 3012787537 • Brzozowka • 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
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 10/15/2025 | 85HHDPAD, MENSTRUAL, UNSCENTED | Division of Northern Border Imports (DNBI) | |
| 7/25/2022 | 63RAL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 7/25/2022 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is FIRMA HANDLOWO-USLUGOWA GABRIEL's FDA import refusal history?
FIRMA HANDLOWO-USLUGOWA GABRIEL (FEI: 3012787537) has 3 FDA import refusal record(s) in our database, spanning from 7/25/2022 to 10/15/2025.
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. FIRMA HANDLOWO-USLUGOWA GABRIEL's FEI number is 3012787537.
What types of violations has FIRMA HANDLOWO-USLUGOWA GABRIEL received?
FIRMA HANDLOWO-USLUGOWA GABRIEL 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 FIRMA HANDLOWO-USLUGOWA GABRIEL come from?
All FDA import refusal data for FIRMA HANDLOWO-USLUGOWA GABRIEL 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.