Hebei Changshan Biochemical Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3005080039 • Shijiazhuang, Hebei • CHINA
FEI Number
3005080039
Location
Shijiazhuang, Hebei
Country
CHINAAddress
9 Fuqiang Road, Zhengding, , 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
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 4/17/2015 | 61LCS08HEPARIN SODIUM (ANTI-COAGULANT) | 3280FRNMFGREG | Southwest Import District Office (SWI-DO) |
| 4/28/2009 | 61LDR08HEPARIN SODIUM (ANTI-COAGULANT) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 4/28/2009 | 61LDR08HEPARIN SODIUM (ANTI-COAGULANT) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 4/28/2009 | 61LDR08HEPARIN SODIUM (ANTI-COAGULANT) | 115DR QUALITY | Los Angeles District Office (LOS-DO) |
| 4/23/2009 | 61LDR08HEPARIN SODIUM (ANTI-COAGULANT) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hebei Changshan Biochemical Pharmaceutical Co., Ltd.'s FDA import refusal history?
Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (FEI: 3005080039) has 5 FDA import refusal record(s) in our database, spanning from 4/23/2009 to 4/17/2015.
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. Hebei Changshan Biochemical Pharmaceutical Co., Ltd.'s FEI number is 3005080039.
What types of violations has Hebei Changshan Biochemical Pharmaceutical Co., Ltd. received?
Hebei Changshan Biochemical 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 Hebei Changshan Biochemical Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Hebei Changshan Biochemical 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.