Amphastar Nanjing Pharmaceuticals Inc
⚠️ High Risk
FEI: 3009805706 • Nanjing, Jiangsu • CHINA
FEI Number
3009805706
Location
Nanjing, Jiangsu
Country
CHINAAddress
Nanjing Economic, No 5 Xinghe Road; And Technological Development Zone, Nanjing, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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.
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
Frequently Asked Questions
What is Amphastar Nanjing Pharmaceuticals Inc's FDA import refusal history?
Amphastar Nanjing Pharmaceuticals Inc (FEI: 3009805706) has 2 FDA import refusal record(s) in our database, spanning from 3/15/2010 to 8/18/2025.
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. Amphastar Nanjing Pharmaceuticals Inc's FEI number is 3009805706.
What types of violations has Amphastar Nanjing Pharmaceuticals Inc received?
Amphastar Nanjing Pharmaceuticals Inc 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 Amphastar Nanjing Pharmaceuticals Inc come from?
All FDA import refusal data for Amphastar Nanjing Pharmaceuticals Inc 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.