Zhejiang Grand Trading Corp.
⚠️ Moderate Risk
FEI: 3001390194 • Ningbo, Zhejiang • CHINA
FEI Number
3001390194
Location
Ningbo, Zhejiang
Country
CHINAAddress
Cai Hong Bldg F/13, , Ningbo, Zhejiang, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/27/2007 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/20/2007 | 74LDESTETHOSCOPE, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 11/8/2006 | 65LBY99PROTECTANT N.E.C. | Baltimore District Office (BLT-DO) | |
| 6/14/2006 | 74DXQCUFF, BLOOD-PRESSURE | Los Angeles District Office (LOS-DO) | |
| 6/14/2006 | 74DXQCUFF, BLOOD-PRESSURE | Los Angeles District Office (LOS-DO) | |
| 5/7/2002 | 94V07TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR | 476NO REGISTR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Zhejiang Grand Trading Corp.'s FDA import refusal history?
Zhejiang Grand Trading Corp. (FEI: 3001390194) has 13 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 11/27/2007.
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 Grand Trading Corp.'s FEI number is 3001390194.
What types of violations has Zhejiang Grand Trading Corp. received?
Zhejiang Grand Trading Corp. has been cited for 5 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 Grand Trading Corp. come from?
All FDA import refusal data for Zhejiang Grand Trading Corp. 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.