Neimenggu Fufeng Biotechnologies Co. Ltd.
⚠️ Moderate Risk
FEI: 3008445761 • Hohhot City, Inner Mongolia • CHINA
FEI Number
3008445761
Location
Hohhot City, Inner Mongolia
Country
CHINAAddress
Jing Er Road, Jinchuan District, Hohhot City, Inner Mongolia, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2013 | 62LDM09TINIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Northeast Imports (DNEI) | |
| 3/7/2013 | 66VDM99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 3/7/2013 | 66VDM99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Neimenggu Fufeng Biotechnologies Co. Ltd.'s FDA import refusal history?
Neimenggu Fufeng Biotechnologies Co. Ltd. (FEI: 3008445761) has 3 FDA import refusal record(s) in our database, spanning from 3/7/2013 to 3/7/2013.
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. Neimenggu Fufeng Biotechnologies Co. Ltd.'s FEI number is 3008445761.
What types of violations has Neimenggu Fufeng Biotechnologies Co. Ltd. received?
Neimenggu Fufeng Biotechnologies 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 Neimenggu Fufeng Biotechnologies Co. Ltd. come from?
All FDA import refusal data for Neimenggu Fufeng Biotechnologies 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.