Ningbo Hooya Imp & Exp Co. Ltd.
⚠️ Moderate Risk
FEI: 3004073092 • Ningbo • CHINA
FEI Number
3004073092
Location
Ningbo
Country
CHINAAddress
8/F., Jianzhu Mansion 202 South, , Ningbo, , 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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2007 | 80FQMBANDAGE, ELASTIC | Florida District Office (FLA-DO) | |
| 9/19/2005 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/14/2005 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 8/31/2004 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Florida District Office (FLA-DO) |
| 8/31/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/31/2004 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ningbo Hooya Imp & Exp Co. Ltd.'s FDA import refusal history?
Ningbo Hooya Imp & Exp Co. Ltd. (FEI: 3004073092) has 6 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 10/22/2007.
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. Ningbo Hooya Imp & Exp Co. Ltd.'s FEI number is 3004073092.
What types of violations has Ningbo Hooya Imp & Exp Co. Ltd. received?
Ningbo Hooya Imp & Exp Co. Ltd. has been cited for 4 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 Ningbo Hooya Imp & Exp Co. Ltd. come from?
All FDA import refusal data for Ningbo Hooya Imp & Exp 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.