Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd.
⚠️ Moderate Risk
FEI: 3005786148 • Shijiazhuang, Hebei • CHINA
FEI Number
3005786148
Location
Shijiazhuang, Hebei
Country
CHINAAddress
No 276 Zhongshan West Rd, , 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
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 |
|---|---|---|---|
| 2/26/2002 | 64BCS45THEOBROMINE (DIURETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd.'s FDA import refusal history?
Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd. (FEI: 3005786148) has 1 FDA import refusal record(s) in our database, spanning from 2/26/2002 to 2/26/2002.
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. Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd.'s FEI number is 3005786148.
What types of violations has Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd. received?
Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd. has been cited for 1 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 Shijiazhuang Pharmaceutical Group, Huasheng Pharma, Co. Ltd. come from?
All FDA import refusal data for Shijiazhuang Pharmaceutical Group, Huasheng Pharma, 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.