Hunusbio Inc
⚠️ Moderate Risk
FEI: 3010165488 • Gwangjin, Seoul • SOUTH KOREA
FEI Number
3010165488
Location
Gwangjin, Seoul
Country
SOUTH KOREAAddress
7 Guuing, , Gwangjin, Seoul, South Korea
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 9/18/2013 | 65CDY01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | Los Angeles District Office (LOS-DO) | |
| 9/18/2013 | 65CDL01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | Los Angeles District Office (LOS-DO) | |
| 9/18/2013 | 65CDY04BETAINE ANHYDROUS (NUTRIENT/TONIC) | Los Angeles District Office (LOS-DO) | |
| 9/18/2013 | 65CDY01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | Los Angeles District Office (LOS-DO) | |
| 9/18/2013 | 65CDL01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | Los Angeles District Office (LOS-DO) | |
| 9/18/2013 | 65LBL99PROTECTANT N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/18/2013 | 65LBL99PROTECTANT N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/18/2013 | 53GC06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hunusbio Inc's FDA import refusal history?
Hunusbio Inc (FEI: 3010165488) has 9 FDA import refusal record(s) in our database, spanning from 9/18/2013 to 9/18/2013.
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. Hunusbio Inc's FEI number is 3010165488.
What types of violations has Hunusbio Inc received?
Hunusbio Inc 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 Hunusbio Inc come from?
All FDA import refusal data for Hunusbio Inc 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.