Yichang Sanxia Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3003274512 • Yichang, Hubei • CHINA
FEI Number
3003274512
Location
Yichang, Hubei
Country
CHINAAddress
No. 8 Ziyang Avenue, Dianjun, Yichang, Hubei, 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2019 | 56DBS41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 4/13/2016 | 56DCT41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 11/10/2015 | 56DYY41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Yichang Sanxia Pharmaceutical Co., Ltd.'s FDA import refusal history?
Yichang Sanxia Pharmaceutical Co., Ltd. (FEI: 3003274512) has 3 FDA import refusal record(s) in our database, spanning from 11/10/2015 to 6/5/2019.
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. Yichang Sanxia Pharmaceutical Co., Ltd.'s FEI number is 3003274512.
What types of violations has Yichang Sanxia Pharmaceutical Co., Ltd. received?
Yichang Sanxia 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 Yichang Sanxia Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Yichang Sanxia 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.