Shanghai Asia Pioneer Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004060008 • Shanghai, Shanghai • CHINA
FEI Number
3004060008
Location
Shanghai, Shanghai
Country
CHINAAddress
92 Zhangjianglu, , Shanghai, Shanghai, 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).
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 |
|---|---|---|---|
| 3/25/2005 | 56DCS31KANAMYCIN SULFATE (AMINOGLYCOSIDES) | New York District Office (NYK-DO) | |
| 3/7/2005 | 56DJS11DIHYDROSTREPTOMYCIN SULFATE (AMINOGLYCOSIDES) | 72NEW VET DR | New York District Office (NYK-DO) |
| 3/7/2005 | 56DJS21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 72NEW VET DR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Shanghai Asia Pioneer Pharmaceutical Co., Ltd.'s FDA import refusal history?
Shanghai Asia Pioneer Pharmaceutical Co., Ltd. (FEI: 3004060008) has 3 FDA import refusal record(s) in our database, spanning from 3/7/2005 to 3/25/2005.
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. Shanghai Asia Pioneer Pharmaceutical Co., Ltd.'s FEI number is 3004060008.
What types of violations has Shanghai Asia Pioneer Pharmaceutical Co., Ltd. received?
Shanghai Asia Pioneer 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 Shanghai Asia Pioneer Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Shanghai Asia Pioneer 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.