CORUM INC
⚠️ Moderate Risk
FEI: 3006717139 • TAIPEI, Neihu • TAIWAN
FEI Number
3006717139
Location
TAIPEI, Neihu
Country
TAIWANAddress
6 F.NO 360, DUEI GUANG ROAD, TAIPEI, Neihu, Taiwan
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2013 | 53UD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/14/2013 | 53UD12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/30/2012 | 62SCS03AZELAIC ACID (ANTI-SEBORRHEIC) | Seattle District Office (SEA-DO) | |
| 3/26/2008 | 53PD99OTHER COSMETIC RAW MATERIALS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is CORUM INC's FDA import refusal history?
CORUM INC (FEI: 3006717139) has 4 FDA import refusal record(s) in our database, spanning from 3/26/2008 to 5/14/2013.
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. CORUM INC's FEI number is 3006717139.
What types of violations has CORUM INC received?
CORUM INC 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 CORUM INC come from?
All FDA import refusal data for CORUM 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.