Zhejiang Longde Pharmaceutical Co., Ltd
⚠️ High Risk
FEI: 3008719222 • Hangzhou, Zhejiang • CHINA
FEI Number
3008719222
Location
Hangzhou, Zhejiang
Country
CHINAAddress
No. 510 Shunfeng Road, Yuhang, 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
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 3724DEVGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 6/13/2024 | 80FMFSYRINGE, PISTON | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Zhejiang Longde Pharmaceutical Co., Ltd's FDA import refusal history?
Zhejiang Longde Pharmaceutical Co., Ltd (FEI: 3008719222) has 10 FDA import refusal record(s) in our database, spanning from 6/13/2024 to 6/13/2024.
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. Zhejiang Longde Pharmaceutical Co., Ltd's FEI number is 3008719222.
What types of violations has Zhejiang Longde Pharmaceutical Co., Ltd received?
Zhejiang Longde 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 Zhejiang Longde Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Zhejiang Longde 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.