Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz.
⚠️ Moderate Risk
FEI: 3002806294 • Tiszavasvari, Szabolcs-Szatmar-Bereg • HUNGARY
FEI Number
3002806294
Location
Tiszavasvari, Szabolcs-Szatmar-Bereg
Country
HUNGARYAddress
Kabay Janos Utca 29, , Tiszavasvari, Szabolcs-Szatmar-Bereg, 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
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).
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.
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
UNSAFE SUB
The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.
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 |
|---|---|---|---|
| 3/17/2010 | 62UAS15NOSCAPINE (ANTI-TUSSIVE/COLD) | Los Angeles District Office (LOS-DO) | |
| 3/11/2010 | 62UAS15NOSCAPINE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/17/2005 | 61MCZ31PHENOBARBITAL (ANTI-CONVULSANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz.'s FDA import refusal history?
Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz. (FEI: 3002806294) has 3 FDA import refusal record(s) in our database, spanning from 5/17/2005 to 3/17/2010.
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. Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz.'s FEI number is 3002806294.
What types of violations has Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz. received?
Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz. has been cited for 5 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 Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz. come from?
All FDA import refusal data for Alkaloida Vegyeszeti Gyar zartkoruen mukodo Resz. 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.