Kunming Ansheng Industry & Trade Co., Ltd.
⚠️ Moderate Risk
FEI: 3014383577 • Kunming, Yunnan • CHINA
FEI Number
3014383577
Location
Kunming, Yunnan
Country
CHINAAddress
Rm.102, Unit 1, Bldg. 4, Huazhuang Garden, Rixin East Road, Xish, Kunming, Yunnan, 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
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.
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).
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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2020 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | Division of Northern Border Imports (DNBI) | |
| 8/14/2020 | 62HDY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Kunming Ansheng Industry & Trade Co., Ltd.'s FDA import refusal history?
Kunming Ansheng Industry & Trade Co., Ltd. (FEI: 3014383577) has 2 FDA import refusal record(s) in our database, spanning from 8/14/2020 to 12/9/2020.
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. Kunming Ansheng Industry & Trade Co., Ltd.'s FEI number is 3014383577.
What types of violations has Kunming Ansheng Industry & Trade Co., Ltd. received?
Kunming Ansheng Industry & Trade Co., Ltd. has been cited for 7 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 Kunming Ansheng Industry & Trade Co., Ltd. come from?
All FDA import refusal data for Kunming Ansheng Industry & Trade 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.