Scinopharm Taiwan, Ltd.
⚠️ Moderate Risk
FEI: 3002840477 • Tainan City • TAIWAN
FEI Number
3002840477
Location
Tainan City
Country
TAIWANAddress
No.1, Nan-Ke 8th Road, Shan-Hua, , Tainan City, , 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
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 |
|---|---|---|---|
| 6/8/2015 | 62ICS99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2015 | 62ICS99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2015 | 62ICS99ANTI-NEOPLASTIC N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/12/2014 | 64RCS17ANASTROZOLE (HORMONE) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 5/21/2014 | 62LCY45EFLORNITHINE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 11/22/2013 | 62ICS91PACLITAXEL (ANTI-NEOPLASTIC) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 7/9/2010 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Scinopharm Taiwan, Ltd.'s FDA import refusal history?
Scinopharm Taiwan, Ltd. (FEI: 3002840477) has 7 FDA import refusal record(s) in our database, spanning from 7/9/2010 to 6/8/2015.
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. Scinopharm Taiwan, Ltd.'s FEI number is 3002840477.
What types of violations has Scinopharm Taiwan, Ltd. received?
Scinopharm Taiwan, Ltd. has been cited for 2 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 Scinopharm Taiwan, Ltd. come from?
All FDA import refusal data for Scinopharm Taiwan, 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.