Jiangxi Dongfeng Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3002807345 • Jingdezhen, Jiangxi • CHINA
FEI Number
3002807345
Location
Jingdezhen, Jiangxi
Country
CHINAAddress
Leping Industrial Park, 1 Dongfeng Road; Leping, Jingdezhen, Jiangxi, 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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/18/2011 | 56BIZ82POTASSIUM PHENETHICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | New Orleans District Office (NOL-DO) | |
| 8/14/2006 | 56BCS51PENICILLAMINE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Jiangxi Dongfeng Pharmaceutical Co., Ltd.'s FDA import refusal history?
Jiangxi Dongfeng Pharmaceutical Co., Ltd. (FEI: 3002807345) has 2 FDA import refusal record(s) in our database, spanning from 8/14/2006 to 10/18/2011.
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. Jiangxi Dongfeng Pharmaceutical Co., Ltd.'s FEI number is 3002807345.
What types of violations has Jiangxi Dongfeng Pharmaceutical Co., Ltd. received?
Jiangxi Dongfeng Pharmaceutical Co., Ltd. has been cited for 3 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 Jiangxi Dongfeng Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Jiangxi Dongfeng Pharmaceutical 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.