Jinan Jianfeng Chemical Co., Ltd.
⚠️ Moderate Risk
FEI: 3013761969 • Jinan, Shandong • CHINA
FEI Number
3013761969
Location
Jinan, Shandong
Country
CHINAAddress
On No. 2 Building Of Huaxin Group Room 401 1, No. 792 Hualonglu; Licheng, Jinan, Shandong, 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).
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2020 | 61NIY99ANTI-DEPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/16/2020 | 61NCZ99ANTI-DEPRESSANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/7/2020 | 61NCZ99ANTI-DEPRESSANT N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/7/2020 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/7/2020 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/26/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 2280DIRSEXMPT | Division of Southeast Imports (DSEI) |
| 3/20/2020 | 61NCS99ANTI-DEPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/20/2019 | 61NCR99ANTI-DEPRESSANT N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/8/2017 | 61NCR99ANTI-DEPRESSANT N.E.C. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Jinan Jianfeng Chemical Co., Ltd.'s FDA import refusal history?
Jinan Jianfeng Chemical Co., Ltd. (FEI: 3013761969) has 11 FDA import refusal record(s) in our database, spanning from 9/8/2017 to 6/29/2020.
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. Jinan Jianfeng Chemical Co., Ltd.'s FEI number is 3013761969.
What types of violations has Jinan Jianfeng Chemical Co., Ltd. received?
Jinan Jianfeng Chemical 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 Jinan Jianfeng Chemical Co., Ltd. come from?
All FDA import refusal data for Jinan Jianfeng Chemical 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.