Shijiazhuang Keqin Trading Co., Ltd.
⚠️ Moderate Risk
FEI: 3012349223 • Shijiazhuang, Hebei • CHINA
FEI Number
3012349223
Location
Shijiazhuang, Hebei
Country
CHINAAddress
163 East Huaian Rd, 6 Floor, Jinming Building, Shijiazhuang, Hebei, 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).
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).
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.
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/15/2019 | 66VAD99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2017 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 8/16/2016 | 66YBD99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shijiazhuang Keqin Trading Co., Ltd.'s FDA import refusal history?
Shijiazhuang Keqin Trading Co., Ltd. (FEI: 3012349223) has 3 FDA import refusal record(s) in our database, spanning from 8/16/2016 to 2/15/2019.
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. Shijiazhuang Keqin Trading Co., Ltd.'s FEI number is 3012349223.
What types of violations has Shijiazhuang Keqin Trading Co., Ltd. received?
Shijiazhuang Keqin Trading 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 Shijiazhuang Keqin Trading Co., Ltd. come from?
All FDA import refusal data for Shijiazhuang Keqin Trading 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.