Helia-D Kft.
⚠️ Moderate Risk
FEI: 3012515777 • Budapest, Budapest • HUNGARY
FEI Number
3012515777
Location
Budapest, Budapest
Country
HUNGARYAddress
Seregely Utca 20, , Budapest, Budapest, 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
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 3/22/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/22/2017 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/22/2017 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 3/22/2017 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 3/22/2017 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Helia-D Kft.'s FDA import refusal history?
Helia-D Kft. (FEI: 3012515777) has 5 FDA import refusal record(s) in our database, spanning from 3/22/2017 to 3/22/2017.
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. Helia-D Kft.'s FEI number is 3012515777.
What types of violations has Helia-D Kft. received?
Helia-D Kft. 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 Helia-D Kft. come from?
All FDA import refusal data for Helia-D 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.