Niuer Beauty Essential Co., Ltd
⚠️ High Risk
FEI: 3008653815 • Taipei • TAIWAN
FEI Number
3008653815
Location
Taipei
Country
TAIWANAddress
6f-1, No.618 Rui Guan Rdneihua District, , Taipei, , Taiwan
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).
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.
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 |
|---|---|---|---|
| 10/21/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 10/21/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 54CCK99PROTEIN N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 54CCK99PROTEIN N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 54CCK99PROTEIN N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 54CCK99PROTEIN N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/21/2013 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Niuer Beauty Essential Co., Ltd's FDA import refusal history?
Niuer Beauty Essential Co., Ltd (FEI: 3008653815) has 18 FDA import refusal record(s) in our database, spanning from 10/21/2013 to 10/21/2013.
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. Niuer Beauty Essential Co., Ltd's FEI number is 3008653815.
What types of violations has Niuer Beauty Essential Co., Ltd received?
Niuer Beauty Essential Co., Ltd 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 Niuer Beauty Essential Co., Ltd come from?
All FDA import refusal data for Niuer Beauty Essential Co., Ltd 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.