RFX Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3006712336 • Wuzhou, Guangxi • CHINA
FEI Number
3006712336
Location
Wuzhou, Guangxi
Country
CHINAAddress
No. 18 Dachongli Qianjian Road, , Wuzhou, Guangxi, 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).
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2019 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3120EPHEDALK | Division of Northeast Imports (DNEI) |
| 8/3/2010 | 61EBH99ANTI-ASTHMATIC, N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 66BBH99STIMULANT N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 61HBH99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 65GBH99PIGMENTATION AGENT N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 8/3/2010 | 66SBH99VASODILATOR N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 61QBH99ANTI-DIURETIC N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBH99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62CBH99ANTI-HYPERTENSIVE N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 65CBH99NUTRIENT/TONIC N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GCA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBH99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 61EBA99ANTI-ASTHMATIC, N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 61EBH99ANTI-ASTHMATIC, N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 62GBA99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 64HBL99EXPECTORANT N.E.C. | New York District Office (NYK-DO) | |
| 8/3/2010 | 64HBL99EXPECTORANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is RFX Pharmaceutical Co., Ltd.'s FDA import refusal history?
RFX Pharmaceutical Co., Ltd. (FEI: 3006712336) has 23 FDA import refusal record(s) in our database, spanning from 8/3/2010 to 10/16/2019.
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. RFX Pharmaceutical Co., Ltd.'s FEI number is 3006712336.
What types of violations has RFX Pharmaceutical Co., Ltd. received?
RFX 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 RFX Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for RFX 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.