Hangzhou HETD Industry Co., Ltd.
⚠️ High Risk
FEI: 3005327439 • Hangzhou, Zhejiang • CHINA
FEI Number
3005327439
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Sandun, 8 Xiyuan No. 1 Road, Hangzhou, Zhejiang, 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
REFUSE EI
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2015 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3600REFUSE EI | Los Angeles District Office (LOS-DO) |
| 8/27/2015 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3600REFUSE EI | Los Angeles District Office (LOS-DO) |
| 8/27/2015 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3600REFUSE EI | Los Angeles District Office (LOS-DO) |
| 8/27/2015 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3600REFUSE EI | Los Angeles District Office (LOS-DO) |
| 8/27/2015 | 54BBR01CALCIUM (MINERAL) | 308MFR INSAN | Los Angeles District Office (LOS-DO) |
| 10/23/2014 | 64RCS17ANASTROZOLE (HORMONE) | 3845DRG REF EI | Southwest Import District Office (SWI-DO) |
| 10/23/2014 | 55YP99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 5/9/2014 | 64RCS17ANASTROZOLE (HORMONE) | 3600REFUSE EI | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hangzhou HETD Industry Co., Ltd.'s FDA import refusal history?
Hangzhou HETD Industry Co., Ltd. (FEI: 3005327439) has 8 FDA import refusal record(s) in our database, spanning from 5/9/2014 to 8/27/2015.
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. Hangzhou HETD Industry Co., Ltd.'s FEI number is 3005327439.
What types of violations has Hangzhou HETD Industry Co., Ltd. received?
Hangzhou HETD Industry 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 Hangzhou HETD Industry Co., Ltd. come from?
All FDA import refusal data for Hangzhou HETD Industry 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.