ZHEJIANG FAVORHOT INDUSTRIAL CO., LTD.
⚠️ Moderate Risk
FEI: 3010218221 • Ningbo, Zhejiang • CHINA
FEI Number
3010218221
Location
Ningbo, Zhejiang
Country
CHINAAddress
Changhe, Cixi, 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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2020 | 62HAK99ANTI-MICROBIAL N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/12/2020 | 62HAK99ANTI-MICROBIAL N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/12/2020 | 62HAK99ANTI-MICROBIAL N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/16/2018 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 5/16/2018 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 5/16/2018 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/10/2015 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 4/10/2015 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ZHEJIANG FAVORHOT INDUSTRIAL CO., LTD.'s FDA import refusal history?
ZHEJIANG FAVORHOT INDUSTRIAL CO., LTD. (FEI: 3010218221) has 8 FDA import refusal record(s) in our database, spanning from 4/10/2015 to 11/12/2020.
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 FAVORHOT INDUSTRIAL CO., LTD.'s FEI number is 3010218221.
What types of violations has ZHEJIANG FAVORHOT INDUSTRIAL CO., LTD. received?
ZHEJIANG FAVORHOT INDUSTRIAL CO., LTD. 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 FAVORHOT INDUSTRIAL CO., LTD. come from?
All FDA import refusal data for ZHEJIANG FAVORHOT INDUSTRIAL 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.