Jinan Chenghui-Shuangda Chemical Co., Ltd.
⚠️ Moderate Risk
FEI: 3006403771 • Jinan, Shandong • CHINA
FEI Number
3006403771
Location
Jinan, Shandong
Country
CHINAAddress
Chengchuan Industrial Park, South Of Kaituo Road; Gaoxin-Kaifa District, 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).
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.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2019 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/23/2019 | 61NCR99ANTI-DEPRESSANT N.E.C. | 16DIRECTIONS | Division of Northern Border Imports (DNBI) |
| 3/31/2017 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/8/2016 | 65WIR99SEROTONIN INHIBITOR N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/11/2012 | 60QDR41MEPIVACAINE HCL (ANESTHETIC) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/25/2011 | 60QCS45PRILOCAINE HCL (ANESTHETIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 3/24/2010 | 60QAS34DIBUCAINE (ANESTHETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/17/2009 | 60QCS52TETRACAINE HCL (ANESTHETIC) | Chicago District Office (CHI-DO) | |
| 1/28/2009 | 61EAS08LORATADINE (ANTI-ASTHMATIC) | Los Angeles District Office (LOS-DO) | |
| 6/9/2008 | 60QCA69PRAMOXINE HCL (ANESTHETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Jinan Chenghui-Shuangda Chemical Co., Ltd.'s FDA import refusal history?
Jinan Chenghui-Shuangda Chemical Co., Ltd. (FEI: 3006403771) has 11 FDA import refusal record(s) in our database, spanning from 6/9/2008 to 6/19/2019.
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. Jinan Chenghui-Shuangda Chemical Co., Ltd.'s FEI number is 3006403771.
What types of violations has Jinan Chenghui-Shuangda Chemical Co., Ltd. received?
Jinan Chenghui-Shuangda Chemical Co., Ltd. has been cited for 8 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 Chenghui-Shuangda Chemical Co., Ltd. come from?
All FDA import refusal data for Jinan Chenghui-Shuangda 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.