HSIN TEN HEALTH & WEALTH INTL
⚠️ Moderate Risk
FEI: 3004666560 • TAIPEI, TW-TPQ • TAIWAN
FEI Number
3004666560
Location
TAIPEI, TW-TPQ
Country
TAIWANAddress
NO 67 , 7TH FLOOR , SEC 1, CHUNG SAN ROAD, HSIN CHUANG, TAIPEI, TW-TPQ, 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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/9/2010 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 10/4/2007 | 54ECT99HERBALS & BOTANICAL TEAS, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 9/25/2007 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/24/2007 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is HSIN TEN HEALTH & WEALTH INTL's FDA import refusal history?
HSIN TEN HEALTH & WEALTH INTL (FEI: 3004666560) has 5 FDA import refusal record(s) in our database, spanning from 9/24/2007 to 8/9/2010.
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. HSIN TEN HEALTH & WEALTH INTL's FEI number is 3004666560.
What types of violations has HSIN TEN HEALTH & WEALTH INTL received?
HSIN TEN HEALTH & WEALTH INTL 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 HSIN TEN HEALTH & WEALTH INTL come from?
All FDA import refusal data for HSIN TEN HEALTH & WEALTH INTL 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.