Jiangsu Ouyali Daily Cosmetic Co., Ltd.
⚠️ Moderate Risk
FEI: 3013842038 • Yangzhou, Jiangsu • CHINA
FEI Number
3013842038
Location
Yangzhou, Jiangsu
Country
CHINAAddress
No.9-9, Chuangye Rd., Shatou Town,Guangling Dist, , Yangzhou, Jiangsu, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2018 | 76JESFLOSS, DENTAL | Division of Northeast Imports (DNEI) | |
| 9/25/2018 | 53IG99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/4/2015 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 12/4/2015 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2015 | 63R06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/25/2015 | 53IA02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 197COSM COLOR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Jiangsu Ouyali Daily Cosmetic Co., Ltd.'s FDA import refusal history?
Jiangsu Ouyali Daily Cosmetic Co., Ltd. (FEI: 3013842038) has 6 FDA import refusal record(s) in our database, spanning from 2/25/2015 to 10/16/2018.
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. Jiangsu Ouyali Daily Cosmetic Co., Ltd.'s FEI number is 3013842038.
What types of violations has Jiangsu Ouyali Daily Cosmetic Co., Ltd. received?
Jiangsu Ouyali Daily Cosmetic Co., Ltd. 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 Jiangsu Ouyali Daily Cosmetic Co., Ltd. come from?
All FDA import refusal data for Jiangsu Ouyali Daily Cosmetic 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.