Helia-D Kft. - Veszpremi Telephely
⚠️ High Risk
FEI: 3010566998 • Veszprem, Veszprem • HUNGARY
FEI Number
3010566998
Location
Veszprem, Veszprem
Country
HUNGARYAddress
Hazgyari Ut 5-7, , Veszprem, Veszprem, Hungary
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 6/24/2015 | 53HC99OTHER MANICURING PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53HC99OTHER MANICURING PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LI10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/24/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Helia-D Kft. - Veszpremi Telephely's FDA import refusal history?
Helia-D Kft. - Veszpremi Telephely (FEI: 3010566998) has 13 FDA import refusal record(s) in our database, spanning from 6/24/2015 to 6/24/2015.
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. - Veszpremi Telephely's FEI number is 3010566998.
What types of violations has Helia-D Kft. - Veszpremi Telephely received?
Helia-D Kft. - Veszpremi Telephely has been cited for 2 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. - Veszpremi Telephely come from?
All FDA import refusal data for Helia-D Kft. - Veszpremi Telephely 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.