Hebei Houde Hanfang Medical Devices Co., Ltd.
⚠️ High Risk
FEI: 3008693666 • Shijiazhuang, Hebei • CHINA
FEI Number
3008693666
Location
Shijiazhuang, Hebei
Country
CHINAAddress
Jinhe Int'L Business Bldg. A Room 1603, Huaan West Street, Shijiazhuang, Hebei, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2025 | 66VID99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/17/2025 | 79FRODRESSING, WOUND, DRUG | 341REGISTERED | Division of Southwest Imports (DSWI) |
| 8/22/2019 | 66VAD99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/26/2019 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/21/2015 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 336INCONSPICU | Cincinnati District Office (CIN-DO) |
| 5/22/2015 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 5/8/2015 | 79KGXTAPE AND BANDAGE, ADHESIVE | 508NO 510(K) | Cincinnati District Office (CIN-DO) |
| 1/8/2015 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Hebei Houde Hanfang Medical Devices Co., Ltd.'s FDA import refusal history?
Hebei Houde Hanfang Medical Devices Co., Ltd. (FEI: 3008693666) has 8 FDA import refusal record(s) in our database, spanning from 1/8/2015 to 12/10/2025.
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. Hebei Houde Hanfang Medical Devices Co., Ltd.'s FEI number is 3008693666.
What types of violations has Hebei Houde Hanfang Medical Devices Co., Ltd. received?
Hebei Houde Hanfang Medical Devices Co., Ltd. has been cited for 8 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 Hebei Houde Hanfang Medical Devices Co., Ltd. come from?
All FDA import refusal data for Hebei Houde Hanfang Medical Devices 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.