Ningbo Hiking Imp & Exp Co., Ltd.
⚠️ Moderate Risk
FEI: 3004548672 • Ningbo • CHINA
FEI Number
3004548672
Location
Ningbo
Country
CHINAAddress
Room 2209, 139 Yaohank Street, 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
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).
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
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 |
|---|---|---|---|
| 11/30/2011 | 76ECGSTERILIZER, BOILING WATER | Division of Southeast Imports (DSEI) | |
| 10/11/2006 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/27/2006 | 89ITQJOINT, KNEE, EXTERNAL BRACE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ningbo Hiking Imp & Exp Co., Ltd.'s FDA import refusal history?
Ningbo Hiking Imp & Exp Co., Ltd. (FEI: 3004548672) has 3 FDA import refusal record(s) in our database, spanning from 2/27/2006 to 11/30/2011.
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 Hiking Imp & Exp Co., Ltd.'s FEI number is 3004548672.
What types of violations has Ningbo Hiking Imp & Exp Co., Ltd. received?
Ningbo Hiking Imp & Exp Co., Ltd. has been cited for 6 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 Hiking Imp & Exp Co., Ltd. come from?
All FDA import refusal data for Ningbo Hiking 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.