Xingchen Health Product Shop
⚠️ Moderate Risk
FEI: 3008548670 • Guangzhou • CHINA
FEI Number
3008548670
Location
Guangzhou
Country
CHINAAddress
153 Duobao Road, , Guangzhou, , China
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
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/7/2011 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/7/2011 | 64XDR06SALICYLIC ACID (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/7/2011 | 64XDR06SALICYLIC ACID (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 7/7/2011 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 7/7/2011 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 5/10/2011 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/10/2011 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Xingchen Health Product Shop's FDA import refusal history?
Xingchen Health Product Shop (FEI: 3008548670) has 7 FDA import refusal record(s) in our database, spanning from 5/10/2011 to 7/7/2011.
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. Xingchen Health Product Shop's FEI number is 3008548670.
What types of violations has Xingchen Health Product Shop received?
Xingchen Health Product Shop 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 Xingchen Health Product Shop come from?
All FDA import refusal data for Xingchen Health Product Shop 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.