Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API).
⚠️ Moderate Risk
FEI: 3003663256 • Xianju, Zhejiang • CHINA
FEI Number
3003663256
Location
Xianju, Zhejiang
Country
CHINAAddress
15 West Fengxi Road, Modern Industrial Park, , Xianju, Zhejiang, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
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.
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 |
|---|---|---|---|
| 4/13/2016 | 64LCT50PREDNISOLONE (GLUCOCORTICOID) | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 9/21/2015 | 64LCS50PREDNISOLONE (GLUCOCORTICOID) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 1/4/2011 | 62KOY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | New Orleans District Office (NOL-DO) | |
| 9/8/2010 | 55PP01GLUCOSAMINE (PHARMACEUTIC NECESSITY) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 9/8/2010 | 67B99CATEGORY II, N.E.C., TYPE A MEDICATED ARTICLE | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 9/3/2009 | 62KIS10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/24/2004 | 65JIY38MIFEPRISTONE (PROGESTIN) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API).'s FDA import refusal history?
Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). (FEI: 3003663256) has 7 FDA import refusal record(s) in our database, spanning from 3/24/2004 to 4/13/2016.
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. Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API).'s FEI number is 3003663256.
What types of violations has Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). received?
Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). 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 Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). come from?
All FDA import refusal data for Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). 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.