Chuangyi Health And Beauty Suppl
⚠️ Moderate Risk
FEI: 3008896222 • Shenzhen • CHINA
FEI Number
3008896222
Location
Shenzhen
Country
CHINAAddress
75157 Xiazhuang Road, , Shenzhen, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2012 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 11/15/2012 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Cincinnati District Office (CIN-DO) | |
| 10/24/2012 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Cincinnati District Office (CIN-DO) | |
| 10/23/2012 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 4/20/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Chuangyi Health And Beauty Suppl's FDA import refusal history?
Chuangyi Health And Beauty Suppl (FEI: 3008896222) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2012 to 11/23/2012.
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. Chuangyi Health And Beauty Suppl's FEI number is 3008896222.
What types of violations has Chuangyi Health And Beauty Suppl received?
Chuangyi Health And Beauty Suppl 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 Chuangyi Health And Beauty Suppl come from?
All FDA import refusal data for Chuangyi Health And Beauty Suppl 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.