BEREKALJA SALES KFT.
⚠️ Moderate Risk
FEI: 3025359013 • Miskolc, Borsod-Abauj-Zemplen • HUNGARY
FEI Number
3025359013
Location
Miskolc, Borsod-Abauj-Zemplen
Country
HUNGARYAddress
Endrodi Sandor Utca 28/B, , Miskolc, Borsod-Abauj-Zemplen, Hungary
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
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
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 |
|---|---|---|---|
| 1/11/2023 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 1/3/2023 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 1/3/2023 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 1/3/2023 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is BEREKALJA SALES KFT.'s FDA import refusal history?
BEREKALJA SALES KFT. (FEI: 3025359013) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2023 to 1/11/2023.
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. BEREKALJA SALES KFT.'s FEI number is 3025359013.
What types of violations has BEREKALJA SALES KFT. received?
BEREKALJA SALES KFT. has been cited for 6 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 BEREKALJA SALES KFT. come from?
All FDA import refusal data for BEREKALJA SALES KFT. 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.