CSPC Innovation Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004090732 • Shijiazhuang, Hebei • CHINA
FEI Number
3004090732
Location
Shijiazhuang, Hebei
Country
CHINAAddress
No. 36, FuQiang Road, Luancheng County, Shijiazhuang, Hebei, 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).
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
Refusal History
Frequently Asked Questions
What is CSPC Innovation Pharmaceutical Co., Ltd.'s FDA import refusal history?
CSPC Innovation Pharmaceutical Co., Ltd. (FEI: 3004090732) has 2 FDA import refusal record(s) in our database, spanning from 10/26/2012 to 9/2/2015.
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. CSPC Innovation Pharmaceutical Co., Ltd.'s FEI number is 3004090732.
What types of violations has CSPC Innovation Pharmaceutical Co., Ltd. received?
CSPC Innovation Pharmaceutical Co., 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 CSPC Innovation Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for CSPC Innovation 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.