Shen-Fu Pharmaceutic Co., Ltd.
⚠️ Moderate Risk
FEI: 3001610218 • Taipei • TAIWAN
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).
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.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2006 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/4/2006 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/27/2005 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 12/8/2004 | 62CDC99ANTI-HYPERTENSIVE N.E.C. | Los Angeles District Office (LOS-DO) | |
| 12/8/2004 | 66SDC99VASODILATOR N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shen-Fu Pharmaceutic Co., Ltd.'s FDA import refusal history?
Shen-Fu Pharmaceutic Co., Ltd. (FEI: 3001610218) has 5 FDA import refusal record(s) in our database, spanning from 12/8/2004 to 4/4/2006.
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. Shen-Fu Pharmaceutic Co., Ltd.'s FEI number is 3001610218.
What types of violations has Shen-Fu Pharmaceutic Co., Ltd. received?
Shen-Fu Pharmaceutic Co., Ltd. has been cited for 4 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 Shen-Fu Pharmaceutic Co., Ltd. come from?
All FDA import refusal data for Shen-Fu Pharmaceutic 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.