Yangzhou Olande Cosmetic Co., Ltd
⚠️ Moderate Risk
FEI: 3011570434 • Yangzhou, Jiangsu • CHINA
FEI Number
3011570434
Location
Yangzhou, Jiangsu
Country
CHINAAddress
Xinglong Road, Hangjizhen Hanjiang, 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
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).
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.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2021 | 62HAL99ANTI-MICROBIAL N.E.C. | Division of West Coast Imports (DWCI) | |
| 1/5/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/28/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 11/13/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 9/24/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Yangzhou Olande Cosmetic Co., Ltd's FDA import refusal history?
Yangzhou Olande Cosmetic Co., Ltd (FEI: 3011570434) has 5 FDA import refusal record(s) in our database, spanning from 9/24/2020 to 1/31/2021.
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. Yangzhou Olande Cosmetic Co., Ltd's FEI number is 3011570434.
What types of violations has Yangzhou Olande Cosmetic Co., Ltd received?
Yangzhou Olande Cosmetic Co., Ltd has been cited for 6 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 Yangzhou Olande Cosmetic Co., Ltd come from?
All FDA import refusal data for Yangzhou Olande 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.